Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation
Conditions: Cochlear Hearing Loss
Sponsor: Advanced Bionics AG

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Retrospective analysis of long-term speech performance in cochlear 
implant recipients using electro-acoustic stimulation 
Reference ID: ABIntl-23-12 
Version: 1 
Version Date: 01/17/2024 
 
Contact information 
 
Sponsor
Advanced Bionics AG 
Laubisrütistrasse 28 
CH-8712 Stäfa 
Switzerland 
Representative in the EU
Advanced Bionics GmbH 
Feodor-Lynen- Strasse 35 
30625 Hannover 
Germany 
Study Manager 
Gunnar Geissler 
Advanced Bionics GmbH 
Feodor-Lynen- Strasse 35 
30625 Hannover 
Germany 
Principal Investigator 
Prof. Andreas Büchner 
Scientific Director 
Medizinische Hochschule Hannover (MHH) 
Deutsches Hörzentrum Hannover (DHZ) 
Karl-Wiechert-Allee 3 
30625 Hannover 
Germany 
 
 
 
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1.0 SYNOPSIS ...................................................................................................................................................... 5 
2.0 GLOSSARY AND ABBREVIATIONS .................................................................................................................. 6 
3.0 BACKGROUND AND PURPOSE OF THE INVESTIGATION ................................................................................. 6 
4.0 INVESTIGATIONAL DEVICE DESCRIPTION ....................................................................................................... 6 
4.1 MANUFACTURER DETAILS .................................................................................................................................... 6 
4.2 DEVICE IDENTIFICATION ....................................................................................................................................... 7 
4.3 GENERAL DESCRIPTION ........................................................................................................................................ 7 
4.3.1 
General Description of a Cochlear Implant (CI) System .................................................................... 7 
4.3.2 
Description of Implantable Cochlear Stimulator (ICS) ...................................................................... 8 
4.3.3 
Description of external components ................................................................................................. 9 
4.3.4 
Description of Software .................................................................................................................. 10 
4.4 DEVICE SPECIFIC DESCRIPTION ............................................................................................................................ 10 
4.5 PRINCIPLE OF OPERATION .................................................................................................................................. 20 
4.6 ORIGIN OF DEVELOPMENT.................................................................................................................................. 21 
4.7 MATERIALS IN CONTACT WITH TISSUES ................................................................................................................. 21 
4.8 DESCRIPTION TRACEABILITY ................................................................................................................................ 23 
4.9 SUMMARY OF THE NECESSARY TRAINING ............................................................................................................... 24 
5.0 STUDY DESIGN AND JUSTIFICATION .............................................................................................................24 
5.1 DESCRIPTION AND JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION ...................................................... 24 
5.2 EVALUATION OF THE RESULTS OF THE REVELANT PRE-CLINICAL TESTING AND PRIOR CLINICAL INVESTIGATIONS ..................... 24 
5.3 EVALUATION OF RELEVANT CLINICAL DATA ............................................................................................................ 24 
5.4 DESCRIPTION OF THE CLINICAL DEVELOPMENT STAGE ............................................................................................... 25 
5.5 DESCRIPTION OF THE MEASURES TAKEN TO MINIMIZE OR AVOID BIAS, INCLUDING RANDOMIZATION AND BLINDING/MASKING 25 
5.6 DESCRIPTION OF THE SPECIFIC MEDICAL OR SURGICAL PROCEDURES ............................................................................ 25 
5.7 NUMBER OF INVESTIGATIONAL DEVICES ................................................................................................................ 25 
5.8 DESCRIPTION OF THE EXPOSURE TO THE INVESTIGATIONAL DEVICE .............................................................................. 25 
5.9 LIST OF ANY OTHER MEDICAL DEVICE OR MEDICATION TO BE USED DURING THE CLINICAL INVESTIGATION ........................... 25 
5.10 DEFINITION OF COMPLETION OF THE CLINICAL INVESTIGATION ................................................................................... 26 
6.0 OBJECTIVES ..................................................................................................................................................26 
6.1 PRIMARY EFFICACY OBJECTIVE ............................................................................................................................ 26 
6.2 SECONDARY EFFICACY OBJECTIVE ........................................................................................................................ 26 
7.0 STUDY PROTOCOL ........................................................................................................................................27 
7.1 SUBJECT POPULATION AND SELECTION CRITERIA .................................................................................................... 27 
7.1.1 
Number of subjects ......................................................................................................................... 27 
7.1.2 
Description of procedures for the selection of subject.................................................................... 27 
7.1.3 
Inclusion Criteria ............................................................................................................................. 27 
7.1.4 
Exclusion criteria ............................................................................................................................. 27 
7.1.5 
Anticipated distribution of enrolment and period of enrolment .................................................... 27 
7.1.6 
Point of randomization ................................................................................................................... 27 
7.1.7 
Expected duration of each subject participation ............................................................................ 28 
7.1.8 
Total expected duration of the study .............................................................................................. 28 
7.2 STUDY ENDPOINTS ........................................................................................................................................... 28 
7.2.1 
Primary Efficacy endpoint ............................................................................................................... 28 
7.2.2 
Secondary Efficacy endpoint ........................................................................................................... 28 
7.2.3 
Safety Endpoint............................................................................................................................... 28 

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7.3 STUDY PROCEDURES ......................................................................................................................................... 28 
7.3.1 
Description of all the clinical investigation related procedures for the subjects ............................ 28 
7.3.2 
Measurements procedures ............................................................................................................. 29 
7.3.3 
Methods and timing for assessing, recording and analyzing variables .......................................... 30 
7.3.4 
Equipment to be used for assessing the clinical investigation variables ........................................ 30 
7.3.5 
Description of those activities performed by Sponsor representatives........................................... 30 
7.3.6 
Any known or foreseeable factors that may compromise the outcome of the clinical investigation 
or the interpretation of results .......................................................................................................................... 30 
7.3.7 
Methods for addressing these factors in the clinical investigation ................................................ 30 
7.3.8 
Specific subject’s follow-up after termination of the study ............................................................ 30 
7.4 STUDY VISITS AND VISIT WINDOWS ..................................................................................................................... 30 
7.5 WITHDRAWAL OF SUBJECTS ............................................................................................................................... 31 
8.0 STATISTICS ...................................................................................................................................................31 
8.1 SAMPLE SIZE JUSTIFICATION ............................................................................................................................... 31 
8.2 STATISTICAL DESIGN & DATA ANALYSIS ................................................................................................................ 31 
8.2.1 
Analytical procedures ..................................................................................................................... 31 
8.2.2 
Primary efficacy hypothesis ............................................................................................................ 31 
8.2.3 
Secondary efficacy hypothesis ........................................................................................................ 32 
9.0 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...............................................................................................32 
10.0 INFORMED CONSENT PROCESS ....................................................................................................................33 
11.0 VULNERABLE POPULATION ..........................................................................................................................33 
12.0 BENEFITS AND RISKS ....................................................................................................................................34 
12.1 RISKS ASSOCIATED WITH PARTICIPATION IN THE CLINICAL INVESTIGATION ..................................................................... 34 
12.2 ANTICIPATED CLINICAL BENEFITS.......................................................................................................................... 34 
12.3 ANTICIPATED ADVERSE DEVICE EFFECTS, RESIDUALS RISKS AND POSSIBLE INTERACTIONS WITH CONCOMITANT MEDICAL 
TREATMENTS .............................................................................................................................................................. 34 
12.4 BENEFIT-RISK RATIO .......................................................................................................................................... 35 
13.0 SUSPENSION OR PREMATURE TERMINATION ..............................................................................................35 
14.0 MONITORING, DEVICE ACCOUNTABILITY AND DATA MANAGEMENT ..........................................................35 
14.1 MONITORING PROCEDURES ............................................................................................................................... 35 
14.2 DEVICE ACCOUNTABILITY ................................................................................................................................... 35 
14.3 DATA MANAGEMENT PROCEDURES / CASE REPORT FORMS ..................................................................................... 35 
14.4 PROCEDURES USED FOR DATA REVIEW, DATABASE CLEANING, AND ISSUING AND RESOLVING DATA QUERIES ........................ 36 
14.5 PROCEDURES FOR VERIFICATION, VALIDATION AND SECURING OF ELECTRONIC CLINICAL DATA SYSTEM (IF APPLICABLE) .......... 36 
14.6 PROCEDURES TO MAINTAIN AND PROTECT SUBJECT PRIVACY ..................................................................................... 36 
14.7 PROCEDURES FOR DATA RETENTION ..................................................................................................................... 36 
14.8 SPECIFIED RETENTION PERIOD ............................................................................................................................. 36 
14.9 OTHER ASPECTS OF CLINICAL QUALITY ASSURANCE, AS APPROPRIATE .......................................................................... 37 
15.0 STATEMENTS OF COMPLIANCE ....................................................................................................................37 
16.0 AMENDMENTS AND DEVIATIONS.................................................................................................................37 
16.1 DESCRIPTION OF THE PROCEDURES TO AMEND THE CIP ........................................................................................... 37 
16.2 DEVIATIONS .................................................................................................................................................... 37 
17.0 PUBLICATION POLICY ...................................................................................................................................37 

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18.0 BIBLIOGRAPHY .............................................................................................................................................37 
19.0 STUDY SITES, INVESTIGATORS AND EXTERNAL ORGANIZATIONS .................................................................38 
19.1 STUDY SITES AND INVESTIGATORS ....................................................................................................................... 38 
19.2 EXTERNAL ORGANIZATIONS ................................................................................................................................ 38 
20.0 REVISION HISTORY (IF APPLICABLE) .............................................................................................................38 
CIP SPONSOR SIGNATURE PAGE ...........................................................................................................................39 
CIP INVESTIGATOR SIGNATURE PAGE ...................................................................................................................40 
 
 
 
 

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1.0  Synopsis 
Study Title
Retrospective analysis of long-term speech performance in cochlear implant 
recipients using electro-acoustic stimulation 
Sponsor  
Advanced Bionics AG 
Investigational Device 
Naída CI M and Naída CI Q and associated acoustic earhooks 
Study Design 
A monocentric observational post-market clinical follow-up study (PMCF) based 
on a retrospective data analysis of anonymized clinical data 
Study Population 
All subjects fulfilling inclusion and exclusion criteria and registered in clinical 
patient database at the time of the extraction of the data 
Inclusion Criteria 
Being implanted with Ultra or Ultra 3D SlimJ 
Being a user of the "acoustic earhook" system 
Having provided informed consent regarding use of his/her data for research 
Exclusion Criteria 
N/A 
Primary Study/Efficacy 
Objective 
Mean monosyllabic word recognition score with the EAS system in quiet at 
twelve months after first fitting of 30% or better 
Primary Study/Efficacy 
Endpoint 
Group average on the Freiburger Monosyllabic Word Test (in quiet) of 30% or 
more at twelve-month after first fitting 
Secondary 
Study/Efficacy Objective 
Mean sentence recognition score with the EAS system in quiet at twelve months 
after first fitting of 40% or better 
Secondary 
Study/Efficacy Endpoint 
Group average in the HSM sentence test (in quiet) of 40% or more at twelve-
month after first fitting  
Safety Objective 
N/A 
PMCF 
Objective 
(if 
required) 
Collection of additional clinical data on acoustic earhook performance 
Study 
Schedule 
& 
Duration 
Estimated time for data collection, analysis and writing of the report: 3 months
 
 
 

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2.0 Glossary and Abbreviations 
(S)AE
(Serious) Adverse Event
BTE
Behind-the-ear
CIP
Clinical Investigation Plan
CPI
Clinician Programming Interface
CRF
Case Report Forms
dB
Decibel
EAS 
Electro Acoustic Stimulation  
EC 
Ethics Committee 
HA 
Hearing Aid 
ICF 
Informed Consent Form 
ICS 
Implantable Cochlear Stimulator 
IRB 
Institutional Review Board 
SNHL 
Sensorineural hearing loss 
SNR 
Signal-to-noise ratio 
SPL 
Sound Pressure Level 
3.0 Background and Purpose of the Investigation 
Some subjects who have had a cochlear implant retain some residual aidable hearing, using a 
specific accessory called an acoustic earhook. This device provides acoustic stimulation just as a 
hearing aid would do, in addition to the electrical stimulation provided by the implant. The aim 
of the study is to collect data on the use of the acoustic earhook. This suggests that there is an 
interest in understanding how this accessory is used by patients after implantation. 
 
This clinical study will be conducted to assess, within the scope of its intended purpose, devices 
which bear the CE mark and where the investigation would not involve submitting subjects to 
procedures additional to those performed under the normal conditions of use, per MDR (EU) 
2017/745 Article 82. 
4.0 Investigational Device Description 
4.1 
Manufacturer details 
Manufacturer details and authorized EU representative are detailed in the following tables (Table 
1, Table 2). 
 
 

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Table 1 - Manufacturer contact details 
Device 
Naída CI M and accessories 
Naída CI Q and accessories 
Legal 
manufacturer 
name 
Advanced Bionics, LLC 
Currently, Advanced Bionics, LLC 
At the time the subject received their sound 
processor, Advanced Bionics AG was the legal 
manufacturer. 
Address 
28515 Westinghouse Place, Valencia, CA 91355, 
USA 
Laubisrütistrasse 28, 8712 Stäfa, Switzerland 
SRN 
US-MF-000019344 
N/A 
PRRC 
Ankur Kaushal 
N/A 
E-mail 
Ankur.Kaushal@advancedbionics.com 
N/A 
Phone 
+1 661 210 5683 
N/A 
 
Table 2 - Authorized Representative contact details 
Authorized 
representative 
Advanced Bionics GmbH 
Address 
Feodor-Lynen-Strasse 35, D-30625 Hannover, Germany 
SRN 
DE-AR-000005642 
PRRC 
Carolin Frohne-Buechner 
E-mail 
carolin.frohne-buechner@advancedbionics.com 
Phone 
+49 511 5248 75 22 
4.2 
Device identification 
Devices under investigation are identified in the table below (Table 3).  
Table 3 - Devices identification  
Model Number 
Sales Description 
Basic UDI-DI 
CI-5280-xxx  
Naída CI Q90  
08400944CI5280Y5  
Cl-5850-xxx  
Naída Cl Q90 Acoustic Earhook  
08400944CI5850YS  
CI-5293-xxx 
Naída CI M90 Sound Processor 
08400944CI5293YE 
CI-5295-xxx 
Sky CI M90 Sound Processor 
08400944CI5295YJ 
CI-5851-xxx 
M Acoustic Earhook 
08400944CI5851YU 
-xxx specify models for color/size 
4.3 
General description 
4.3.1 General Description of a Cochlear Implant (CI) System 
A cochlear implant system consists of: 
·       Internal components - Implantable cochlear stimulator (or ‘implant’) 
·       External components - Sound processor with cables, headpiece, earhook, batteries etc. 
·       Software - Fitting software, remote application. 
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4.3.2 Description of Implantable Cochlear Stimulator (ICS) 
The internal component or implant includes a receiver and an electrode which are both 
implanted surgically under the skin behind the ear. 
The implant electronics are contained within a hermetically sealed titanium case with a 
removable magnet and telemetry coil (RF antenna) attached and encased in silicone. The antenna 
coil assembly receives power and data over an inductively coupled link from the external sound 
processor system. The electrode consists of a fantail, electrode lead, and electrode array. Figure 
1 illustrates the ICS. 
* 
 
Figure 1 1: Example of a cochlear implant: HiResTM Ultra 3D CI with HiFocusTM Mid-Scala electrode 
 
The HiFocus SlimJ electrode consists of an electrode lead and electrode array. The electrode 
contacts are housed in a silicone carrier, referred to as the electrode array. The wires, composed 
of platinum-iridium alloy, are housed in a silicone carrier, referred to as the electrode lead, and 
extend from the titanium case of the HiRes Ultra or Ultra 3D.  
The HiFocus SlimJ electrode is approximately 23 mm in length (from blue marker to distal tip) 
and is designed to be inserted approximately 420° into a normal patient cochlea (Figure 2) The 
array consists of 16 planar contacts arranged along the medial (inside) surface of the electrode 
array for stimulation of discrete segments of the cochlea. The electrode contacts are numbered 
1 through 16 from apex to base, and spaced so that the contacts fall in similar locations in the 
cochlea as with the HiFocus Mid-Scala electrode. There is one blue marker on the electrode array, 
positioned proximal to the 16th contact and placed adjacent to a raised feature on the electrode 
silicone carrier. The total electrode lead and fantail length is approx. 77.6 mm. This includes the 
distal, thin portion of the lead up to the ‘wing’ feature, which allows for better visualization 
during electrode array implantation. 
The SlimJ electrode can be inserted using a free-hand technique using the Forceps and the 
HiFocus Mid-Scala electrode reusable metal tools, which includes two identical cochleostomy 
recess gauges and two identical claw tools. 
 

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Figure 2 : HiFocus SlimJ Electrode 
4.3.3 Description of external components 
 Sound processor 
The sound processor is available in two functionally similar configurations: off-ear (body-worn) 
and behind-the-ear (BTE). All sound processors and headpieces function as follows: soundwaves 
in the environment are captured through the microphone located on the processor, in the 
headpiece, T-Mic or auxiliary input devices. The processor then converts this sound information 
into a digital signal that is transferred through the headpiece to the implant. The headpiece 
contains a magnet which couples with the implant’s magnet to keep the headpiece in place over 
the implant.  
 Headpiece 
The headpiece contains an omni-directional microphone which picks up sounds. The sound signal 
is passed down the headpiece cable to the sound processor, which analyzes the sound and 
converts it to a digital signal. The signal is sent back along the headpiece cable to the headpiece, 
where it is sent transcutaneously to the implant. Figure 3 provides an example of the external 
components (sound processor, battery) and some accessories (cable, headpiece, microphones) 
 
 
Figure 3 : Example of the external components of a cochlear implant system 

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4.3.4 Description of Software 
The Programming Software system consists of a standard personal computer running Microsoft 
Windows with approved Advanced Bionics fitting software and Clinician Programming Interface 
(CPI). An audiologist or other trained health professional uses the fitting software to set 
parameters in a strategy to tailor a program for a specific recipient. System diagnostic functions 
of the system are also available in the software. The CPI provides a bridge between the computer 
and the sound processor.  
4.4 
Device Specific description  
Marvel (Naída CI M) and Naída CI Q sound processors series uses the same Acoustic Earhook, 
there is no clinical difference between the devices so no distinction will be made hereafter in this 
clinical investigation plan (CIP). 
 
The description and specifications of the devices used in this study are detailed in the table below 
(Table 4). 
Table 4 : Device Description and Specification 
General description of the device 
CI-5280-xxx 
- 
Naída CI Q90 
Naída CI sound processors are behind-the-ear (BTE) sound processors that 
convert sound picked up by the microphone into electrical signals that are 
used by the cochlear implant to enable hearing. Naida CI sound processor 
is comprised of the components pictured below. They offer multiple power 
options and wearing options for the user. The system is designed to provide 
useful hearing to individuals with severe-to-profound hearing loss. 
 
Cl-5850-xxx - 
Naída Cl Q90 
Acoustic 
Earhook 
The Naida CI Q90 Acoustic Earhook allows for the addition of acoustic 
amplification to the electrical stimulation traditionally produced by a 
cochlear implant. The Acoustic Earhook attaches to the Naida CI Q90 Sound 
Processor with the processor connector. From the processor connector, a 
tube extends to the xReceiver Unit that transfers sound inputs through the 
sound outlet into the ear’s auditory canal. The Acoustic Earhook contains a 
dash on the side of the xReceiver Unit, that acts as a guide for the loop of 
the optional Retention Hook, and a colored indicator on the xReceiver Unit, 
blue for the left ear and red for the right ear. 
 
CI-5293-xxx 
(Naída CI M90) 
CI-5295-xxx (Sky 
CI M90) 
The Marvel CI sound processors (Naída CI M90, and Sky CI M90) are BTE 
sound processors for use with an Advanced Bionics cochlear implant.  
The sound processors feature direct connectivity to wireless accessories 
and Bluetooth® technology enabled devices. They offer multiple power 
options and wearing options for the user. 
The system is designed to provide useful hearing to individuals with severe-
to-profound hearing loss. 
The Marvel CI sound processors are behind-the-ear sound processors 
available as three variants:  the Naída CI M90 (“premium” offering), the 
Naída CI M30 (“essential” offering), and the Sky CI M90 (pediatric offering).  
The hardware is identical across the three variants, with access to different 
software features controlled by the firmware resident on the processor. 
 

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CI-5851-xxx (M 
Acoustic 
Earhook) 
The M Acoustic Earhook is an attachment to the Advanced Bionics Naída CI 
M90 and Sky CI M90 sound processors. The M Acoustic Earhook allows for 
the addition of acoustic amplification to the electrical stimulation 
traditionally produced by a cochlear implant. From the sound processor 
connector, a cable extends to the speaker unit that transfers sound inputs 
through the sound outlet into the ear canal. There are 5 sizes of the M 
Acoustic Earhook for right and left ears to accommodate different ear sizes 
and shapes. Domes attach to the speaker unit of the acoustic earhook to 
provide a comfortable fit in the ear canal.  The connector pins and pin 
removal tool are also included. 
 
 
Intended use 
CI-5280-xxx 
- 
Naída CI Q90 
The Naida CI sound processors are accessories of an auditory active implantable system, the 
HiResolution™ Bionic Ear system. The HiResolution™ Bionic Ear system is intended to provide auditory 
sensation via electrical stimulation of the auditory nerve for individuals with severe to profound 
bilateral or unilateral sensorineural hearing loss. 
Cl-5850-xxx - 
Naída Cl Q90 
Acoustic 
Earhook 
The Naida Q90 Acoustic Earhook provides acoustic amplification for patients with aidable low frequency 
hearing. 
CI-5293-xxx 
(Naída CI M90) 
CI-5295-xxx (Sky 
CI M90) 
The Naída™ CI M90 sound processor is a behind the ear (BTE) sound processor which works together 
with the implant to bypass the damaged part of the inner ear and converts sound picked up by the 
microphone or streamed via wireless communication into electrical signals that are used by the 
cochlear implant to enable hearing. 
The Naída CI M90 is the premium version with full access to multiple automatic programs and features 
including bimodal and bilateral and supports compatibility with acoustic amplification. 
The Sky CI M90 sound processor can be used by both adults and children and provides dedicated 
pediatric hearing solution (multiple color options, and adjustable program for individual pediatric 
users). The Sky CI M90 provides full access to multiple automatic programs and features including 
bimodal and bilateral and supports compatibility with acoustic amplification. 
CI-5851-xxx (M 
Acoustic 
Earhook) 
The M Acoustic Earhook provides acoustic amplification for patients with aidable low frequency 
hearing. 
The M Acoustic Earhook coupled with the Naída CI M90 or Sky CI M90 sound processor is intended to 
provide acoustic amplification and electrical stimulation to Advanced Bionics cochlear implant 
recipients. 
Intended use environment 
CI-5280-xxx - 
Naída CI Q90 
The Naida Q sound processor system is intended for use in healthcare and home environments. The 
home environment is extended to include use outdoors and during travel (e.g., airplanes).  
The Naída Q sound processor system is intended to operate with the SoundWave fitting software, and 
with Phonak RemoteMic, DECT Phone, Roger, TVLink II, MyPilot control devices or ComPilot devices 
used for audio streaming. 
The user is responsible for security of connections with other devices, including pairing the sound 
processor with other devices in a secure environment. 
Cl-5850-xxx - 
Naída Cl Q90 
Acoustic 
Earhook 
The intended use environments of the Naida Q90 Acoustic Earhook are healthcare and daily living 
environments. The Naida Q90 Acoustic Earhook, are designed to be worn daily during the user’s normal 
waking hours. 

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CI-5293-xxx 
(Naída CI M90) 
CI-5295-xxx (Sky 
CI M90) 
The intended use environments of the Marvel CI sound processors are healthcare and daily living 
environments.  They are designed to be worn daily during the user’s normal waking hours 
CI-5851-xxx (M 
Acoustic 
Earhook) 
The intended use environments of the M Acoustic Earhook are healthcare and daily living 
environments. The M Acoustic Earhook are designed to be worn daily on the skin over the implant 
during the user’s normal waking hours. 
Intended users 
CI-5280-xxx - 
Naída CI Q90 
The intended users of the Naída CI Sound Processors are recipients of Advanced Bionics cochlear 
implants, their caregivers if applicable, and hearing care professionals. The recipient, or their caregiver, 
should, at a minimum, be capable of changing the battery, connecting the earhook, placing and 
removing the sound processor from their ear, and placing and removing the headpiece from the implant 
site. The hearing care professional should be trained in the use and fitting of the cochlear implant 
system. 
Cl-5850-xxx - 
Naída Cl Q90 
Acoustic 
Earhook 
The intended users of the Naida Q90 Acoustic Earhook are users of the Naida CI Sound Processors, their 
caregivers if applicable, and hearing care professionals.  
The recipient, or their caregiver, should, at a minimum, be capable of changing the battery, connecting 
the earhook, placing and removing the sound processor from their ear, and placing and removing the 
headpiece from the implant site.  
The hearing care professional should be trained in the use and fitting of the cochlear implant system. 
CI-5293-xxx 
(Naída CI M90) 
CI-5295-xxx (Sky 
CI M90) 
The intended users of the Marvel CI sound processors are recipients of Advanced Bionics cochlear 
implants, their caregivers if applicable, and hearing care professionals.   
The recipient, or their caregiver, should, at a minimum, be capable of changing the battery, connecting 
the earhook, placing and removing the sound processor from their ear, and placing and removing the 
headpiece from the implant site.  
The hearing care professional should be trained in the use and fitting of the cochlear implant system.     
CI-5851-xxx (M 
Acoustic 
Earhook)  
The intended users of the M Acoustic Earhook are recipients of the Neptune, Naída CI Q, Naída CI M, or 
Sky CI M sound processors, their caregivers if applicable, and hearing care professionals. 
The recipient, or their caregiver, should, at a minimum, be capable of changing the battery, connecting 
the earhook, placing and removing the sound processor from their ear, and placing and removing the 
headpiece from the implant site. 
The hearing care professional should be trained in the use and fitting of the cochlear implant system. 
Intended patient population 
Adults – 18 years of age or older  
Children – 12 months through 17 years of age 
Medical condition(s) 
Information on the clinical condition 
The clinical condition of relevance is sensorineural hearing loss, a condition affecting the ability of the inner ear to process 
and pass auditory information to the brain. This is different from a conductive hearing loss, resulting from physical obstruction 
or mechanical failure delivering the signal to the inner ear. The most common type of permanent hearing loss is sensorineural 
hearing loss (it is the cause of more than ninety percent (90%)1 of hearing loss in adults). 
Sensorineural hearing loss is categorized by frequency (low to high) and by degree (mild, moderate, severe, or profound). The 
World Health Organization (WHO) documentation describes disabling hearing as a loss of 40 dB or greater (moderate hearing 
loss), indicating that this degree of hearing loss affects the person’s ability to function normally. The onset of hearing loss can 
be congenital or acquired, sudden or progressive, in one ear or both, and can vary in degree from low to high frequencies. 
Leading causes of sensorineural hearing loss include inherited disorders, noise exposure, and presbycusis (hearing loss due to 
normal aging)2. With greater the degrees of sensorineural hearing loss, less benefit is provided by amplifying the sound 
through devices such as a hearing aid. This results in degraded awareness, understanding, and can negatively impact 
interactions with others. 

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Untreated hearing loss can negatively impact cortical development, speech and language acquisition, environmental 
awareness, stress, and even cognitive health. Appropriate diagnosis and intervention can help to minimize the impact of 
hearing loss. 
Prevalence of the condition 
WHO estimates that 466 million people (6% of the global population) have disabling hearing loss. It is estimated that by 2050 
over 900 million people will have disabling hearing loss. The Center for Disease Control reports a prevalence of hearing loss 
of approximately 0.1% in children. The National Institute on Deafness and Communication Disorders estimates this to be a 
bit higher at 0.2% or 0.3%. They report about 2% of adults aged 45-54 have disabling hearing loss. The rate increases to 8.5% 
for adults 55-64. Nearly 25% in adults 65-74 and as high as 50% for those 75 and older3. 
Natural course of the condition 
Sensorineural hearing loss occurs in response to a number of factors, with variable time course, severity, and configuration. 
Hearing loss can manifest at birth (congenital) or begin later in life. It can be severe at onset or progress gradually over time. 
It can be associated with known factors like genetics, syndromes, comorbidities (diabetes, stroke, tumor) or events (trauma, 
noise exposure). It can affect one or both ears. The degree of hearing loss can even change by frequency, allowing audibility 
of low pitch sounds but not high pitch sounds. 
Several studies have documented the impact of untreated hearing loss. An often-cited survey was commissioned by the 
National Council on Aging in 19994. This nationwide survey of nearly 4,000 adults with hearing loss and their significant others 
showed significantly higher rates of depression, anxiety, and other psychosocial disorders in individuals with hearing loss who 
were not wearing hearing aids. These findings were consistent with the findings of a large randomized controlled study which 
found that hearing loss was associated with decreased social/emotional, communication, and cognitive function in addition 
to increased depression for subjects who were unaided as compared to those who received hearing aids5. 
More recently, Dr. Frank Lin and his colleagues at Johns Hopkins University found a strong link between degree of hearing 
loss and risk of developing dementia. Individuals with mild hearing loss were twice as likely to develop dementia as those 
with normal hearing, those with moderate hearing loss were three times more likely, and those with severe hearing loss had 
five times the risk. While this study could not definitively conclude that early treatment with hearing aids would reduce the 
risk of dementia, there was a positive correlation between degree of hearing loss and risk of dementia6. 
A WHO report on the global costs of unaddressed hearing loss points to significant costs to the educational sector ($3.9 
billion), productivity ($105 billion), and society ($573 billion) per year7. They conclude that hearing aids and cochlear implants 
are a cost-effective strategy in treatment of hearing loss. 
References 
1. 
Deafness and hearing loss. (n.d.). Retrieved October 24, 2020, from https://www.who.int/news-room/fact-
sheets/detail/deafness-and-hearing-loss 
2. 
Isaacson, J. E., & Vora, N. M. (2003). Differential diagnosis and treatment of hearing loss. American family physician, 
68(6), 1125–1132. Tyagi, Rout: A Revolutionary Treatment of Sensorineural Hearing Loss, 2019, ResearchGate 
3. 
US National institute for deafness and other communication disorders - Based on calculations performed by NIDCD 
Epidemiology and Statistics Program staff: (1) using data from the 1999-2010 National Health and Nutrition Examination 
Survey (NHANES); (2) applying the definition of disabling hearing loss used by the 2010 Global Burden of Disease Expert. 
Hearing Loss Team (hearing loss of 35 decibels or more in the better ear, the level at which adults could generally benefit 
from hearing aids). https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing 
4. 
Kochkin, S., & Rogin, C. M. A. (2000). Quantifying the obvious: The impact of hearing instruments on quality of life. 
Hearing Review, 7(1), 8–34. 
5. 
Mulrow, C. D., Aguilar, C., Endicott, J. E., Velez, R., Tuley, M. R., Charlip, W. S., & Hill, J. A. (1990). Association between 
hearing impairment and the quality of life of elderly individuals. Journal of the American Geriatrics Society, 38(1), 45–50. 
6. 
Lin, F. R., Metter, E. J., O’Brien, R. J., Resnick, S. M., Zonderman, A. B., & Ferrucci, L. (2011). Hearing loss and incident 
dementia. Archives of Neurology, 68, 214–220. 
7. 
Global costs of unaddressed hearing loss and cost-effectiveness of interventions: a WHO report, 2017 ISBN 978-92-4-
151204-6 
Indication(s) 
The Naída CI Sound Processors and Accessories are external components of the HiResolution™ Bionic Ear System, which is 
intended to restore a level of auditory sensation to individuals with severe-to-profound sensorineural hearing loss via electrical 
stimulation of the auditory nerve. 
 
Adults 
o 
Severe-to-profound bilateral sensorineural hearing loss or severe-to-profound unilateral hearing loss. 

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o 
Postlingual onset of severe or profound hearing loss. 
o 
Limited benefit from appropriately fitted hearing aids, defined as scoring 50% or less on a test of open-set 
sentence recognition (HINT Sentences). 
 
Children 
o 
Severe-to-profound bilateral sensorineural deafness or severe-to-profound unilateral hearing loss. 
o 
Use of appropriately fitted hearing aids for at least 6 months in children 2 through 17 years of age, or at 
least 3 months in children 12 through 23 months of age. The minimum duration of hearing aid use is waived 
if x-rays indicate ossification of the cochlea. 
o 
Little or no benefit from appropriately fitted hearing aids. In younger children (< 4 years of age), lack of 
benefit is defined as a failure to reach developmentally appropriate auditory milestones (such as 
spontaneous response to name in quiet or to environmental sounds) measured using the Infant-Toddler 
Meaningful Auditory Integration Scale or Meaningful Auditory Integration Scale or ≤20% correct on a simple 
open-set word recognition test (Multisyllabic Lexical Neighborhood Test) administered using monitored live 
voice (70 dB SPL). In older children (≥ 4 years of age), lack of hearing aid benefit is defined as scoring ≤12% 
on a difficult open- set word recognition test (Phonetically Balanced-Kindergarten Test) or ≤30% on an 
open-set sentence test (Hearing In Noise Test for Children) administered using recorded materials in the 
soundfield (70 dB SPL). 
Contraindications 
 
Deafness due to lesions of the acoustic nerve or central auditory pathway 
 
Active external or middle ear infections 
 
Cochlear ossification that prevents electrode insertion 
 
Absence of cochlear development 
 
Tympanic membrane perforations associated with recurrent middle ear infections 
Precautions, Cautions & Warnings 
CI-5280-xxx - 
Naída CI Q90 
o 
This device should be used only by the individual for whom it is prescribed. 
o 
CHOKING HAZARD: contains small parts that pose a hazard of inhalation or choking. 
o 
Do not use a ComPilot if recipient has a pacemaker, as there is potential for interference. 
Contact a healthcare professional for more information. 
o 
Do not use or store the AB myPilot in shirt pockets if the recipient has a pacemaker, as there is 
potential for interference. Contact a healthcare professional for more information. 
o 
Ensure appropriate supervision when child is wearing the Naída CI sound processor and 
accessories. 
o 
Keep batteries and accessories out of children’s reach as they may pose a choking hazard. 
o 
If any parts are swallowed consult a physician or hospital immediately. 
o 
Do not allow children to play with or leave them unattended with batteries. 
o 
Do not place batteries in your mouth. 
o 
Do not chew or swallow batteries. If this occurs, seek immediate medical attention. 
o 
Do not allow children to play with or operate the drying system unattended. 
o 
Using your sound processor and accessories contradictory to their intended use (e.g. mouthing, 
chewing) may cause bodily harm 
o 
Do not recharge disposable batteries. 
o 
Do not allow leaking battery fluid to come into contact with skin, mouth, or eyes. 
o 
Do not expose batteries to heat (e.g., do not store in direct sunlight or in a hot car). 
o 
Do not dispose of batteries in fire. 
o 
Do not allow children to charge batteries unattended. 

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o 
Do not use any other power supply with the sound processor, AB myPilot remote control or 
ComPilot unless it is supplied by Advanced Bionics or Phonak. If needed call Advanced Bionics for a 
power supply replacement. 
o 
Do not use the AB myPilot or the ComPilot when they are plugged in to power sources such as 
wall outlets or other power sources that are USB compatible such as laptops. 
o 
The ComPilot comes with a neck loop antenna; do not touch the neck loop connectors at the 
same time. 
o 
Unplug the neck loop from the ComPilot before pairing your ComPilot to a Bluetooth device to 
avoid unexpected sounds. 
o 
Do not attempt to pair your ComPilot while driving or operating heavy machinery. 
o 
Do not stream music to your ComPilot while driving or operating heavy machinery. 
o 
Use your ComPilot for hands-free phone use only where permitted by law and only when you 
will not be distracted from the safe operation of your motor vehicle. 
o 
Power supplies and battery chargers should be operated in an open area to ensure adequate 
airflow. While no injury cases have resulted, components may become hot during normal use or a fault 
condition. If the device’s temperature results in discomfort or pain when touched, disconnect the 
power source and contact your local Advanced Bionics representative. 
o 
Remove your sound processor and headpiece before entering a room where an MRI scanner is 
located. 
o 
Remove external equipment to stop stimulation if uncomfortable sounds are heard. 
o 
Having the correct magnet strength is important so that the recipient does not experience 
discomfort or retention issues. If an insufficient number of magnets is used in the headpiece, it may fall 
off more than is acceptable. If too many magnets are used in the headpiece, you may experience 
irritation or discomfort. Consult a clinician if there are any concerns regarding magnet strength. If 
deemed appropriate, an audiologist may insert additional magnets or remove magnets from the 
headpiece. Do not place additional magnets in the headpiece unless under the direction of a cochlear 
implant professional. If the recipient experiences any redness, irritation, or discomfort, discontinue use 
of the headpiece immediately and contact a cochlear implant center. See the headpiece “Instructions 
for Use” for additional information regarding adjustment of headpiece magnet strength. 
o 
If the sound processor or accessories become unusually hot, or warm, discontinue use immediately 
and contact Advanced Bionics or a clinician. 
o 
Store additional headpieces away from items with magnetic strips (e.g. credit cards, hotel room 
key cards), as this may de-magnetize cards. 
o 
Portable and mobile RF communications equipment, including radios and cellular phones, may 
affect sound quality of the Naída CI sound processor and accessories; however, there is no safety 
hazard associated with such equipment. 
o 
The Naída CI sound processor and accessories should be used in accordance with the 
electromagnetic compatibility (EMC) information provided in the ‘Guidance and Manufacturer’s 
Declaration’ section of this Instructions for Use. 
o 
Only use the charger provided for charging AB PowerCel™ batteries. DO NOT use it to charge other 
batteries. Do not try to charge PowerCels* using a charger other than the one provided by 
Advanced Bionics. 
o 
Remove batteries from your sound processor when they are drained to prevent damage from 
possible leaking. 
o 
Do not expose any part of the Naída CI sound processor or accessories to extreme heat, such as 
an oven, microwave or hair dryer. 
o 
Do not use your AB myPilot or ComPilot accessories when instructed not to use wireless electronic 
devices, such as on airplanes. 

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o 
The AB myPilot should not come within 1 cm (1/2”) of the Naída CI processor while stimulating the 
implant, as doing so could cause the implant and sound processor to lose lock. If this happens, 
power down the processor and re-power on (done by disengaging the battery and reattaching). 
o 
When operating the device near a computer terminal or other strong electromagnetic fields, it 
may be necessary to be at least 60 cm (24”) away to ensure proper operation. If the Naída CI does 
not respond to the implant device because of an unusual field disturbance, move away from the 
disturbing field. 
o 
If the AB myPilot stops being able to transmit commands to the sound processor, it may be 
necessary to re-pair the AB myPilot with your sound processor. Consult the previous section of this 
user manual for instructions on re-pairing the AB myPilot. 
o 
If volume commands from your AB myPilot to your sound processor seem erratic, re-pair the AB 
myPilot and the Naída CI. 
o 
If the patient and/or caregiver is concerned about underlying skin conditions, have the attending 
physicians contact a dermatologist and/or rheumatologist. 
o 
For Pediatric or immobile patients, if there is any question of discomfort or changes to skin in the 
area of implant or at the location of the external devices, the caregiver must be bring it to the 
attention of the attending physician. 
Additional precautions for Naida CI Q90 sound processor:  
o 
StereoZoom, auto UltraZoom and UltraZoom will dampen sounds that are not in front of the 
recipient. 
o 
Do not use StereoZoom, auto UltraZoom or UltraZoom in an off-the-ear wearing configuration. 
o 
Use of WindBlock, EchoBlock and/or SoundRelax may affect the quality of sound. 
*PowerCels refer to both PowerCels and PowerCel Minis unless otherwise noted 
Cl-5850-xxx - 
Naída Cl Q90 
Acoustic 
Earhook 
o 
The device should be used only by the individual for whom it is prescribed. 
o 
CHOKING HAZARD: Acoustic Earhook contains small parts that could cause choking if swallowed. 
o 
If any parts are swallowed consult a physician or hospital immediately. 
o 
The Acoustic Earhook should only be used by the intended recipient and not by any other 
individual. 
o 
Do not allow children to play with or operate the drying system unattended. 
o 
Using your Acoustic Earhook contradictory to the intended use (i.e. mouthing, chewing) may cause 
bodily harm. 
o 
Remove your sound processor and headpiece before entering a room where an MRI scanner is 
located. 
o 
Remove Acoustic Earhook to stop stimulation if uncomfortably loud sounds are heard. 
o 
If the sound processor or accessories become unusually hot or warm, discontinue use immediately 
and contact your cochlear implant professional. 
o 
Do not expose the Acoustic Earhook to extreme heat, such as an oven, microwave or hair dryer. 
o 
Do not use the Acoustic Earhook unless the Wax Guard is properly seated and the appropriate 
dome is attached. 
o 
In the unlikely event that the dome gets stuck in the ear canal, it is strongly recommended to seek 
medical assistance to safely remove the part. 
o 
Exposure of the receiver to high humidity, sweat, or water could damage the receiver. 
o 
In the unlikely event that the Wax Guard becomes dislodged from the receiver while in the ear 
canal, contact your cochlear implant professional. Do NOT try to remove the Wax Guard from your 
ear canal yourself. 
CI-5293-xxx 
(Naída CI M90) 
• The device should be used only by the individual for whom it is prescribed. 
• CHOKING HAZARD: Contains small parts that pose a hazard of inhalation, choking, or ingestion. Using 
your sound processor and accessories contradictory to their intended use (e.g. mouthing, chewing) 

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CI-5295-xxx (Sky 
CI M90) 
may cause bodily harm. If any parts are swallowed or inhaled, consult a physician or hospital 
immediately.  
• Ensure appropriate supervision when child is wearing the Marvel CI sound processors and 
accessories. Do not allow children to play with or leave them unattended with the sound processor or 
any of its accessories.  
• Power supplies and battery chargers should be operated in an open area to ensure adequate airflow. 
While no injury cases have resulted, components may become hot during normal use or a fault 
condition. If the device’s temperature results in discomfort or pain when touched, disconnect the 
power source and contact your local Advanced Bionics representative.  
• Do not use any other power supply with the sound processor or accessories unless it is supplied by 
Advanced Bionics. If needed, please call Advanced Bionics for a power supply replacement.  
• Do not use accessories when they are plugged into power sources such as wall outlets, or other 
power sources that are USB compatible (e.g. laptops).  
• Do not allow leaking battery fluid to come into contact with skin, mouth, or eyes.  
• Do not expose batteries to heat (e.g., do not store in direct sunlight or in a hot car).  
• Remove batteries from your sound processor when they are drained to prevent damage from 
possible leaking.  
• Do not dispose of batteries in fire.  
• High levels of static electricity may damage electronic components of your sound processor or 
implant. Care should be taken to avoid exposure of the system to static electricity.  
• Do not attempt to pair your sound processor to any accessories while driving or operating heavy 
machinery. 
•Pair the sound processor to Bluetooth devices only in a secure environment. 
•Unwanted paired Bluetooth devices can be overwritten by pairing with authorized devices or can be 
deleted during fitting by your cochlear implant professional.  
• Do not stream audio to your sound processor while driving or operating heavy machinery.  
• Attenuating ambient sounds or adjusting environmental balance while streaming audio (either with 
the multifunction button or with the mobile application) may compromise situational awareness.  
• Use your sound processor for hands-free phone use only where permitted by law and only when 
you will not be distracted from the safe operation of your vehicle.  
• Do not use your Advanced Bionics wireless accessories when instructed not to use wireless 
electronic devices, such as on airplanes.  
• Remove your sound processor and headpiece before entering a room where an MRI scanner is 
located, and prior to having any surgeries that involve electrocautery and diathermy.  
• Remove your sound processor and consult your cochlear implant professional if uncomfortable 
sounds are heard or in case of discomfort, pain or skin irritation.  
• If the sound processor or accessories become unusually hot or warm, discontinue use immediately 
and contact Advanced Bionics or your cochlear implant professional.  
• The large Slim HP Color Cap is for use by recipients older than 3 years of age, as this color cap and 
the Slim HP magnet may become displaced upon dropping.  
• It is important to have the correct magnet strength, so you do not experience discomfort or 
retention issues. If magnet strength is insufficient, the headpiece may fall off more than is 
acceptable. If magnet strength is excessive, you may experience irritation or discomfort. Consult 
your cochlear implant professional if there are any concerns regarding magnet strength. If deemed 
appropriate, an audiologist may change the strength of the magnet in the headpiece. Do not change 
magnet strength unless under the direction of a cochlear implant professional. If you experience any 
redness, irritation, or discomfort, discontinue use of the headpiece immediately and contact a 
cochlear implant professional. See the headpiece instructions for use for additional information 
regarding adjustment of headpiece magnet strength.  
 
• Store additional headpieces away from items with magnetic strips (e.g., credit cards, hotel room 
keys, etc.) as they may de-magnetize cards.  
• The digitally-coded, inductive transmission technology used in this device is extremely reliable and 
experiences virtually no interference from other devices. It should be noted, however, that when 
operating the device near a computer terminal or other strong electromagnetic field (e.g. RFID system) 
, metal detectors, electromagnetic anti-theft systems), it may be necessary to be at least 24” (60 cm) 

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away to ensure proper operation. If the Marvel CI sound processor does not respond to the implant 
device because of an unusual field disturbance, move away from the disturbing field.  
• The Marvel CI sound processors and accessories should be used in accordance with the 
electromagnetic compatibility information provided in the Guidance and Manufacturer’s Declaration 
section of this document.  
• Although electromagnetic emissions of your Marvel CI sound processor have been confirmed within 
safe limits, some other devices could be sensitive to such emissions. If you notice other devices do not 
behave as expected when your sound processor is nearby, separate the devices.  
• Portable and mobile radio frequency (RF) communications equipment, including radios and cellular 
phones, may affect sound quality of the Marvel CI sound processor and accessories; however, there 
is no safety hazard associated with such equipment.  
• Do not expose any part of the Marvel CI sound processors or accessories to extreme heat, such as 
an oven, microwave, or hair dryer.  
• AutoSense OS 3.0 operating system, Speech in Loud Noise, Fixed Directional Mode, UltraZoom, 
UltraZoom + SNR Boost, and Speech in 360 programs may dampen sounds that are not in front of the 
recipient.  
• Use of WindBlock, EchoBlock, SoundRelax, NoiseBlock, and/or WhistleBlock may affect the quality 
of sound.  
• Do not use any programs other than an off-ear program when utilizing any off-ear wearing 
configuration (e.g., in a clip, in the M Waterproof Battery).  
• NOTE: In the United States, Fixed Directional mode, StereoZoom, UltraZoom, SoundRelax, 
NoiseBlock, WindBlock, and EchoBlock are approved for use in pediatric recipients 6 years and above 
who are 1) able to complete objective speech perception testing in order to determine speech 
performance and 2) able to report a preference for different coding strategies or features.  
• In the event that you experience any issues with your product, please contact your cochlear implant 
professional or the manufacturer. Do not attempt to service or modify the Marvel CI or its accessories. 
Doing so may compromise system performance and will void the manufacturer’s warranty. Products 
should be serviced only at Advanced Bionics and damaged products should be returned to Advanced 
Bionics.  
CI-5851-xxx (M 
Acoustic 
Earhook) 
 
This device should be used only by the individual for whom it is prescribed. 
 
CHOKING HAZARD: Contains small parts that pose a hazard of inhalation, choking, or ingestion. 
If any parts are swallowed or inhaled, consult a physician or hospital immediately. 
 
Do not leave children unattended with or allow children to play with the M Acoustic Earhook. 
 
Do not allow children to place the M Acoustic Earhook in the mouth. 
 
The M Acoustic Earhook should only be used by the intended recipient and not by any other 
individual. 
 
Exposure of the M Acoustic Earhook to high humidity, sweat, or water could damage the 
speaker unit. 
 
Placing the M Acoustic Earhook within close proximity to the headpiece magnet may damage 
the M Acoustic Earhook. 
 
Remove your sound processor and consult your cochlear implant professional if 
uncomfortable sounds are heard or in case of discomfort, pain or skin irritation. 
 
Do not use the M Acoustic Earhook unless the earwax protection is properly seated and the 
appropriate dome is attached. 
 
In the unlikely event that the dome or earwax protection becomes dislodged in the ear canal, 
contact your cochlear implant professional. Do not try to remove the dome or earwax protection 
from your ear canal yourself. 
 
If you observe any changes in sound quality with the M Acoustic Earhook, please contact 
Advanced Bionics or your cochlear implant professional. 
In the event that you experience any issues with your product, please contact your cochlear implant 
professional or the manufacturer. Do not attempt to service or modify the Naída CI or its accessories. 
Doing so may compromise system performance and will void the manufacturer’s warranty. Products 
should be serviced only at Advanced Bionics and damaged products should be returned to Advanced 
Bionics. 

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Possible Adverse Events 
CI-5280 (Naída CI Q90 Sound Processors) 
Undesirable side effects of Naída CI system may include skin irritation and discomfort from pressure on the ear, device 
overheating, or overly loud sounds. If any undesirable side effect is encountered, please remove your sound processor and 
consult your cochlear implant professional. 
CI-5850 (Naída Cl Q90 Acoustic Earhook) 
Undesirable side effects of Naída CI system may include skin irritation and discomfort from pressure on the ear, device 
overheating, or overly loud sounds 
CI-5293-xxx (Naída CI M90), CI-5295-xxx (Sky CI M90), CI-5851-xxx (M Acoustic Earhook) 
Undesirable side effects of your Marvel CI sound processor and accessories may include skin irritation and discomfort from 
pressure on the ear, device overheating, or overly loud sounds. If any undesirable side effect is encountered, please remove 
your sound processor and consult your cochlear implant professional. 
Claimed clinical benefit 
The intended clinical benefit of the Naída CI Sound Processor and Accessories as part of the HiRes™ Bionic Ear System is defined 
as: 
 
For adults: 
o 
Word recognition score in quiet higher or equal to 30% at a minimum of 12 months follow-up OR 
improvement higher than 30% compared to pre-operative stage 
AND/OR 
o 
Sentence recognition score in quiet higher or equal to 40% at a minimum of 12 months follow-up OR 
improvement higher than 40% compared to pre-operative stage 
 
For children: 
o 
Before 4 years old: auditory awareness higher than 50% at a minimum of 12 months follow-up 
o 
Above 4 years old: word/sentence recognition in quiet higher than 30% or improvement of 30% at a 
minimum of 12 months follow-up. 
Expected lifetime 
CI-5280-xxx- 
Naída CI Q90 
5 years 
Cl-5850-xxx - 
Naída Cl Q90 
Acoustic 
Earhook 
1 year 
CI-5293-xxx 
(Naída 
CI 
M90) 
CI-5295-xxx 
(Sky CI M90) 
5 years 
CI-5851-xxx 
(M Acoustic 
Earhook) 
1 year 
Invasiveness 
Non-invasive (external) 
Contact duration 
Intact skin, >30 days 
Type of use 

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Single-use* 
Sterile 
Non-sterile 
Novel product 
☐ 
YES 
x 
NO 
Novel related clinical procedure 
☐ 
YES 
x 
NO 
Explanation of any novel features 
N/A 
*Single use as they do not fit the MDR (nor FDA) reprocessing definition of reusable devices. These devices are used on one 
individual during a single procedure corresponding to the lifetime of the devices. 
4.5 
Principle of Operation 
The HiRes™ Bionic Ear System is a cochlear implant system designed to provide useful hearing to 
individuals with severe-to-profound hearing loss. It consists of internal and external components. 
Figure 4 illustrates the connections between CI components, including the fitting software. The 
cochlear implant (internal component), CPI fitting interface and fitting software are not under 
investigation but are included for completeness. 
 
 
Figure 4 : Diagram of the connections between CI components 
Figure 5 illustrates the auditory pathway with the cochlear implant and the behind-the ear sound 
processor. Sound is captured by microphones. Note: Advanced Bionics cochlear implants can 
receive sound from T-Mic, headpiece and processor microphones and auxiliary audio inputs 
sources. 
1. The sound processor converts the captured sound into detailed digital information. 

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2. The processor sends power and digital information via the headpiece to the implant 
which is implanted under the skin. 
3. The implant converts the digital information from the processor into electrical 
stimulation which is delivered to the auditory nerve through the electrode array. The auditory 
(hearing) nerve sends impulses to the brain where they are interpreted as sound. 
 
 
Figure 5 : Auditory pathway of cochlear implant and BTE 
4.6 
Origin of development 
The development of sound processor is based on addition and incrementation of new features 
to existing technologies. The Marvel sound processor is based on a previous generation of 
processor called Naída CI Q which is itself an improvement on the processor generation called 
Harmony. Electro-acoustic stimulation (EAS) was introduced with the Acoustic Earhook with the 
Naída CI Q sound processor. 
4.7 
Materials in contact with tissues 
For each device under investigation, the materials in contact with tissues are listed in tables 
below (Table 5, Table 6, Table 7 and Table 8). Biocompatibility reports for each device and 
materials are available upon request.  
Table 5 : Naída™ CI Q90 material specifications 
Description 
Raw Material 
Colorants 
Direct contact contact with 
human body 
Case Top 
PC/ABS Cycoloy HC1204HF 
 
White 
Color 
Science 
CS4W397C 
Beige 
Color 
Science 
CS4N924C 
Black 
Color 
Science 
CS11K532C 
White Sabic 8H6D029L 
Beige Sabic 5H6D141L 
Black Sabic 7H1D396 
Brown Sabic 5H1D005L 
Skin 
Case Bottom 
Skin 
Program Button 
Skin 
Volume Rocker 
Skin 
XXXXXXXXXXX
XXXXXXXXXXX

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Description 
Raw Material 
Colorants 
Direct contact contact with 
human body 
Gray Sabic 7H5D485L 
Light Pipe 
PC Lexan 243R 
White Sabic 18 625E 
White Sabic 8239 
Skin 
Acoustic Vent Mesh 
Saati Polyester  
N/A 
Skin 
Acoustic 
Vent 
Overmold 
Polyethylene Ineos T50-2000, Black 
PEC45000-709 
N/A 
Skin 
PIN 0.7 x 8.9mm 
Titanium, Grade 5 ELI
N/A
Skin
Earhook Locking Pin 
Titanium Grade 5 ELI (Grade 23) 
Stainless Steel 316** 
N/A 
Skin 
PIN 0.7 x 6.7mm 
Titanium Grade 5 ELI (Grade 23) 
N/A 
No 
P2i Coating (external)
Aridion 120 C1 Fluorocarbon
N/A
Skin
Headpiece Connector 
Body: Beryllium Copper  
Center Contact: Beryllium Copper  
Insulator: PTFE 
Body Finish: N2PGR 
Center Contact Finish: Gold Over 
Nickle  
N/A 
Skin 
BTE 
Connector: 
Housing 
PA66 Grivory GV-5H 
Cool Gray 7 
Skin 
BTE Connector: Detent 
Spring 
Stainless Steel 302 
Stainless Steel 304** 
N/A 
Skin 
Frame 
Vectra A130 VF3001 
Natural 
No 
PIN 0.7 x 7.15mm 
Titanium, Grade 5 ELI (Grade 23) 
N/A 
No 
PIN 0.7 x 5.4mm  
Titanium, Grade 5 ELI (Grade 23) 
N/A 
No 
Microphone 
Suspension (F) 
Fluorosilicone 
Natural 
No 
Microphone 
Suspension (R) 
Fluorosilicone 40 shore A 
Natural  
No 
Seal
Fluorosilicone 25 shore A
Natural
No
 
Table 6 : Naída CI Q90 Acoustic Earhook material specifications 
Description 
Raw Material 
Colorants 
Direct contact or indirect 
contact 
with 
human 
body 
Wire Jacket 
Pebax 7233 SP01 
Clear 
Skin 
Nozzle 
Resin Pebax 7233 SP01 
Clear  
Skin 
Retention
Resin Pebax 7233 SP01
Clear 
Skin
Connector Body 
Resin Grilon TSG 15 
Natural 
Skin 
Connector Socket
Gold plated metal
N/A
Skin
Housing Receiver 
Stainless Steal 316L 
N/A 
Skin 
Housing Receiver Ink 
Morlock M702.1 
1.33 Red 
Skin 
Housing Receiver Ink 
Morlock M702.1 
1.00-HD White 
Skin 
Housing Receiver Ink 
Morlock M702.1 
1.54 Royal Blue 
Skin 
Receiver
N/A
N/A
No
Receiver Cover Front 
PA66 Ultramid A3EG3 
Black TRL 25205 
Skin 
Receiver Cover Back 
PA66 Ultramid A3EG3
Black TRL 25205
Skin
Epoxy Adhesive 
EpoTek 730 + 1.5% Tix 
N/A 
Skin 
CeruStop 
Ektex MED PH23T630 
N/A 
Skin 
Pin 
Removal 
Tool 
Body 
PA66 RTP 
202RcHs Gray 
Skin 
XXXXXXXXXXX
XXXXXXXXXXX

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Description 
Raw Material 
Colorants 
Direct contact or indirect 
contact 
with 
human 
body 
Pin Removal Tool Pin 
Stainless Steel 303, per ASTM A582 
N/A 
Skin 
 
Table 7 : Marvel CI sound processors material specifications 
Description 
Raw Material 
Color 
Direct contact contact with 
human body 
Case Top, Case Bottom, Volume rocker
Grilamid TR XE 4237
Berlac paint
Yes, skin
Light Pipe 
Lexan 243R 
White  
Yes, skin 
Frame
Grivory GV-5H
Blue 
No
Plate T-Mic Pins 
Hostaform C9021 
White 
No 
Contact Pin 
Brass 
N/A 
No 
Suspension Microphone 
Silicone VMQ 10/133 30 
Shore A 
Natural 
No 
Housing Connector BTE, Plate Locator 
BTE Connector 
Grivory GV-5H 
Blue  
Yes 
Battery Contact 
Gold plated metal 
N/A 
No 
Detent Spring
Stainless Steel 302
N/A
Yes, skin
Mic Retention Frame 
Grivory GV-5H 
Blue  
No 
Microphone cover 
Polyester 
N/A 
No 
Mic Seal 
Silicone 12/411 
Black 
No 
Connector Seal 
Silicone VMQ 10/263 Shore 
A 
Blue 
No 
T-Coil Compression Suspension 
Silicone VMQ 10/133 30 
Shore A 
Natural 
No 
Pin 
Titanium Grade 23, 
Precinox PX 
N/A 
No 
Locking Pin
Stainless Steel 316L
N/A
Yes, skin
P2i Coating (external) 
Fluorocarbon 
N/A 
Yes, skin 
 
Table 8 : M Acoustic Earhook material and specifications 
Description 
Raw Material 
Color 
Direct contact contact with 
human body 
Nozzle
Pebax 7033-SA-01 MED
Natural
Yes, skin
Connector 
Grivory GV-5H 
Natural 
Yes, skin 
Inner Mold 
Pebax 7033-SA-01 MED 
Natural 
No 
Wire Jacket 
Pebax 7233-SP-01 
Natural 
Yes, skin 
Cover Back,  Cover Front 
Ultramid A3EG3 
Black 
Yes, skin 
Retention 
Pebax 7033-SA-01 MED 
Natural 
Yes, skin 
O-Ring 
Silicone WMQ 10/263 Shore A 
Blue 
Yes, skin 
Housing Receiver
Stainless Steel 316L
NA
Yes, skin
Housing Receiver Ink 
Morlock M702.1 
Red, White, 
Royal Blue 
Yes, skin 
4.8 
Description traceability 
This project includes retrospective analyses of clinical data. All devices were used in the clinical 
routine and tracked according to the appropriate regulations. 
XXXXXXXXXXX
XXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXX

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4.9 
Summary of the necessary training 
Personnel involved at the center are required to be familiar with the center’s patient database 
and conventions for data coding and be able to extract data from it as well as compare data 
within it to e.g. ensure compliance with the inclusion criteria. Besides being familiar with this 
plan, no specific training is required. 
5.0 Study Design and Justification  
5.1 
Description and justification for the design of the clinical investigation  
This monocentric observational post-market clinical follow-up study (PMCF) of cochlear implants 
with Electro-Acoustic Stimulation is based on a retrospective data analysis of anonymized clinical 
data, in order to minimize risk and effort for the subjects. Reliable data to evaluate the efficacy 
of the Naída CI Q sound processor and the Naída CI M sound processor and their associated 
acoustic earhook, are already available in the form of data collected within the clinical routine. 
Analyses of these data do not have an influence on clinical routine and therefore do not impose 
any additional effort from the subjects.  
A retrospective analysis of clinical data also minimizes the amount of data collected on each 
subject and consequently minimizes the risk of loss of personal data. To further protect subjects’ 
data privacy, only anonymized data will be provided to AB. 
5.2 
Evaluation of the results of the relevant pre-clinical testing and prior 
clinical investigations  
The Naída CI Q sound processor and the Naída CI M sound processor and associated acoustic 
earhook were qualified for long-term use in/on the human body through extensive preclinical 
testing using industry standards and specialized testing targeted for cochlear implants. This 
testing considered anticipated use case stresses which could affect the stability and reliability of 
the device, such as: impact, flexure and tensile stresses; body fluid/tissue contact; anticipated 
medical procedures for the patient and environmental elements. 
The stability of the AB implants is assured by the materials and processes used in the manufacture 
of the devices. Reliable data to evaluate the efficacy of the HiRes Ultra Cl HiFocus SlimJ implant 
and Naída CI Q sound processor and the Naída CI M sound processor and associated acoustic 
earhook are available in the form of data collected within the clinical routine. These data reflect 
real world evidence and are therefore suitable for PMCF objectives. Analyses of these data do 
not have an influence on clinical routine and do therefore not impose any additional effort on 
the subject. 
5.3 
Evaluation of relevant clinical data  
The post market surveillance data including reliability, complaint, adverse events and Corrective 
Action Preventive Action (CAPA) data ensure that safety is consistently monitored. Once 
identified the events are thoroughly investigated, analyzed for root causes and the necessary 
actions taken to mitigate any risks. 

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The literature reviews performed examined all aspects of cochlear implantation clinical 
outcomes. These were conducted according to the state-of-the-art methodology and identified 
a large amount of published literature. The benefits underline the substantial benefits of cochlear 
implantation when applied to selected candidates having severe to profound sensorineural 
hearing loss. 
These considerations indicate that the devices under evaluation have a positive risk/benefit 
profile and hence are suitable for clinical application. The data available from the risk analysis, 
the literature reviews, standards compliance, and data on long-term reliability all indicate that 
the products perform well in comparison to other cochlear implants and accessories that are 
already on the market. 
5.4 
Description of the clinical development stage  
Not applicable, all devices under investigation are CE-marked.  
5.5 
Description of the measures taken to minimize or avoid bias, including 
randomization and blinding/masking  
The cohort shall reflect the general population and represent real world data. The subjects are 
not selected, fulfillment of all inclusion criteria is the one condition. Factors such as gender or 
lifestyle are not expected to have an effect on study outcomes. By selecting all eligible subjects 
from the clinic’s database in the analysis, selection bias is minimized. 
5.6 
Description of the specific medical or surgical procedures 
There are no specific medical or surgical procedures included in this analysis. Cochlear 
implantation and follow-up of the subjects were performed according to the center’s clinical 
routine. 
5.7 
Number of investigational devices 
As this is a retrospective and observational clinical study, the number of devices under 
investigation corresponds to the number of included subjects. Bilateral patients received two 
devices. Therefore, the number of subjects is potentially lower than the number of devices. 
This study will include all patients fulfilling inclusion and exclusion criteria and registered in the 
clinical patient database at the time of data extraction. 
5.8 
Description of the exposure to the investigational device  
Investigational devices are CE marked and used according to their intended purpose as described 
in the IFU. Please, refer to section 4 for the description of the devices. 
5.9 
List of any other medical device or medication to be used during the 
clinical investigation 
As this device is part of a system, the other medical devices used are the components of the 
cochlear implant, i.e., the compatible implant (HiRes Ultra and HiRes Ultra 3D with the SlimJ 
electrode in this study), headpieces and other accessories (connection cables, batteries) which 
are described above. 

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There is no additional medical device or medication involved as part of the study procedure. 
5.10 Definition of completion of the clinical investigation  
Not applicable, this a retrospective observational PMCF study for which data are already 
collected. This investigation will be considered completed when the report is finalized and all 
regulatory requirements are fulfilled, as applicable. 
6.0 Objectives 
6.1 
Primary Efficacy Objective  
The primary efficacy objective is to demonstrate that the group mean monosyllabic word 
recognition score with the EAS system in quiet at twelve months after first fitting is 30% or better. 
This efficacy outcome has been defined in accordance with the State-Of-The-Art (SOTA) 
performed by AB, and claimed clinical benefits for the HiRes Bionic Ear System from AB. 
6.2 
Secondary Efficacy Objective 
The secondary efficacy objective is to demonstrate that the group mean sentence recognition 
score with the EAS system in quiet at twelve months after first fitting is 40% or better. 
Subsidiary objectives include:  
- 
Observation of the evolution of the mean monosyllabic word recognition score with the EAS 
system in quiet at 6, 12 months, 2, 3, 4 and 5 years after first fitting and more if available  
- 
Observation of the evolution of the mean sentence recognition score with the EAS system in 
quiet at 6, 12 months, 2, 3, 4 and 5 years after first fitting and more if available  
- 
Observation of the evolution of the mean sentence recognition score with the EAS system in 
noise at 6, 12 months, 2, 3, 4 and 5 years after first fitting and more if available.  
There are no safety objectives for this clinical investigation. Safety events will not be collected 
retrospectively for the included subjects.  
 

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7.0 Study Protocol 
7.1 
Subject Population and Selection Criteria 
7.1.1 Number of subjects  
As a retrospective analysis, this study will include all patients fulfilling inclusion and exclusion 
criteria and registered in the clinical patient database at the time of the extraction of the data.  
Considering the EAS population already implanted at MHH since January 2017 (estimated at 50 
users) and based on the estimation of patients who provided informed consent and who fulfill 
the inclusion criteria, the size of the included population is estimated to be around 30 to 40 
subjects. 
Any CI recipient from the implicated center (MHH in Hanover, Germany) implanted with an Ultra 
or an Ultra 3D implant and meeting the below defined inclusion criteria will be included. 
7.1.2 Description of procedures for the selection of subject 
This analysis only includes observational retrospective analyses of clinical data. Data related to 
all eligible subjects will be queried from the clinical patient database. 
7.1.3 Inclusion Criteria 
 Being implanted with Ultra or Ultra 3D SlimJ 
 Being a user of the "acoustic earhook" system 
 Having provided informed consent regarding use of his/her data for research. 
7.1.4 Exclusion criteria 
There are no specific exclusion (and non-inclusion) criteria, all patients fulfilling inclusion criteria 
described above and registered in the clinic patient database will be included. 
The absence of exclusion criteria is based on the intention to have an exhaustive approach. By 
eliminating all restrictions, it is expected to include a representative range of participants, 
thereby maximizing the generalizability of the results to the general population. 
7.1.5 Anticipated distribution of enrolment and period of enrolment 
This section is not applicable, this is a retrospective observational study for which data are 
already collected. Patients implanted between January 2017 and August 2022 and fulfilling above 
selection criteria will be included. 
Only one expert center will be part of this study. The center enrolled all patients. 
7.1.6 Point of randomization 
There is no randomization as this is a retrospective observational study on data collected during 
clinical routine.  

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7.1.7 Expected duration of each subject participation 
This section is not applicable. This is a retrospective observational study on data already collected 
with no further subject participation required. Subjects with follow-up up to 5 years after first 
fitting of the Naída CI Q or Naída CI M sound processors and associated earhooks can be included. 
7.1.8 Total expected duration of the study  
This is a retrospective observational study on data already collected. The duration of the 
investigation corresponds to the time needed to analyze the data, prepare the report, and fulfill 
any regulatory requirement, as applicable. A total of 3 months is estimated to analyze the data 
and prepare the report.  
7.2 
Study Endpoints 
7.2.1 Primary Efficacy endpoint  
The primary efficacy endpoint is the group mean Freiburger Monosyllabic Word score (in quiet) 
of 30% or more at twelve months after the first fitting. 
7.2.2 Secondary Efficacy endpoint  
The secondary efficacy endpoint is the group mean HSM score (in quiet) of 40% or more at twelve 
months after the first fitting. 
Subsidiary efficacy endpoints include:  
- 
The mean monosyllabic word recognition score with the EAS system in quiet at 6, 12 months, 
2, 3, 4 and 5 years after the first fitting 
- 
The mean sentence recognition score with the EAS system in quiet at 6, 12 months, 2, 3, 4 
and 5 years after the first fitting 
- 
The mean sentence recognition score with the EAS system in noise at 6, 12 months, 2, 3, 4 
and 5 years after the first fitting. 
Regarding the sentence recognition score, either HSM sentence test or the OlSa recognition score 
were collected during the clinical routine. The center initially collected the HSM sentence test 
routinely and then switched to the OlSa recognition score. Therefore, throughout follow-up the 
speech test used to evaluate performance may have changed. Regarding the secondary objective 
and associated endpoint, the HSM sentence test will be used.  
7.2.3 Safety Endpoint 
This investigation focuses only on performance aspects. This retrospective data analysis is 
conducted for PMCF purpose as required following clinical evaluation of the device. The need for 
additional performance data specific to EAS user was identified. 
7.3 
Study Procedures 
7.3.1 Description of all the clinical investigation related procedures for the subjects 
As a retrospective analysis, this study does not include any investigational procedure outside of 
the clinical routine for the included patients. 

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7.3.2 Measurements procedures 
The original publications describing the tests carried out are presented in the appendices 
(Hahlbrock, 1953, Hochmair-Desoyer et al., 1997 and Wagener et al. 1999). 
Publications demonstrating the accuracy of the Freiburger Monosyllabic Word, Hochmair-Schulz-
Moser and Oldenburger Sentence tests for evaluating speech understanding applied to the 
German language are listed in the bibliography section. Please note that these publications are 
in German. 
- 
Freiburger Monosyllabic Word Test 
The Freiburger Monosyllabic Word Test was conducted with a clinical audiometer. The signal 
was presented at 65dB from a loudspeaker in front of the subject. The loudspeaker 
presenting the material was placed one meter in front of the CI recipient. The score was 
obtained as the percentage of words correctly understood.  
Conditions: at baseline the monosyllabic word test was conducted in free field on the ear to 
be implanted. The patient used the hearing aid setting with which he/she obtained best 
results. The score obtained was the baseline monosyllabic word score. With the CI system the 
monosyllabic word test was measured in free field using the processor in its normally used 
setting. 
- 
Hochmair-Schulz-Moser Sentence Test 
The Hochmair-Schulz-Moser (HSM) Sentence Test was conducted with a clinical audiometer. 
The signal was presented at 65dB from a loudspeaker in front of the subject. The loudspeaker 
presenting the material was placed one meter in front of the CI recipient. The score was 
obtained as the percentage of words correctly understood.  
For speech intelligibility in noise a speech-shaped noise was presented additionally at 55dB 
SPL (SNR of +10dB). 
Conditions: at baseline the HSM test was conducted in free field on the ear to be implanted. 
The patient used the hearing aid setting with which he/she obtained best results. With the CI 
system the HSM test was measured in free field using the processor in its normally used 
setting. 
- 
Oldenburger Sentence Test (OlSa) 
The Oldenburger Sentence Test was performed in an adaptive way using a clinical 
audiometer. Both, signal and noise, were presented from the loudspeaker in front of the 
subject. The noise was presented at 65dB in a continuous way. The signal was varied to 
obtain the signal-to-noise ratio at which the patient correctly understood 50% of the words. 
This is called Speech Reception Threshold (SRT) measured in dB.  
Conditions: at baseline the Olsa was conducted in free field on the ear to be implanted. The 
patient used the hearing aid setting with which he/she obtained best results. The SRT 
obtained in this condition was the baseline SRT. With the CI system the OlSa was measured 
in free field using the processor in its normally used setting. 

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7.3.3 Methods and timing for assessing, recording and analyzing variables 
The data collected for this retrospective observational study were already collected by the expert 
center as part of the clinical routine management of patients. Analysis to be performed for this 
investigation is described in section 8.2. 
7.3.4 Equipment to be used for assessing the clinical investigation variables 
To obtain speech perception scores and in the Freiburger monosyllabic word test, the HSM 
sentence test and speech reception threshold in the Oldenburger sentence test, the clinics used 
a standard audiometer where the respective tests are implemented. 
7.3.5 Description of those activities performed by Sponsor representatives 
The anonymized data will be analyzed by the Sponsor and a report will be provided to the 
investigator. The Sponsor is responsible for any regulatory requirements, as applicable. 
7.3.6 Any known or foreseeable factors that may compromise the outcome of the clinical 
investigation or the interpretation of results 
The study carried out is a monocentric study, which may constitute a bias: the population may 
not reflect the overall population using the acoustic earhook. Additionally, only anonymized data 
will be provided to AB, preventing the possibility to verify source data. Therefore, no monitoring 
will be performed for this investigation. 
7.3.7 Methods for addressing these factors in the clinical investigation 
There are no methods for addressing the potential bias due to the study being monocentric 
within the clinical investigation, except performing additional clinical investigations in other 
centers. 
In order to ensure the validity of the transmitted data, a contract will be drawn up between the 
centre and AB with the aim of defining roles and responsibilities. The center will be responsible 
for the verification of the validity of the data. 
7.3.8 Specific subject’s follow-up after termination of the study  
Not applicable, this a retrospective observational study for which the data were already collected 
in the context of the clinical routine care. 
7.4 
Study Visits and Visit Windows 
All data analyzed will be collected retrospectively from the clinical database, no dedicated visits 
are necessary for this protocol. The scheduled routine of patient care visits is presented in the 
Error! Reference source not found.. 
 

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Table 9 : Schedule of clinical routine patient care visits at MHH 
Procedures 
Pre-Op 
Surgery 
First 
Fitting 
Follow-up 
fitting 
(3 
and 6 Mo) 
Yearly Appointment 
(1 year, 2, 3, 4, 5… 
years) 
Counselling, 
selection 
of 
implant 
manufacturer  
X 
 
 
 
 
Pure tone audiometry 
X 
 
X 
X 
X 
Implantation of cochlear implant 
 
X 
 
 
 
Implant check 
 
X 
X 
X 
X 
Imaging  
 
X 
 
 
 
Rehabilitation training 
X
Medical check 
X 
 
X 
 
X 
Speech perception test 
X
X
X
X
Finetuning of fitting  
 
 
X 
X 
X 
 
7.5 
Withdrawal of Subjects 
This section is not applicable to a retrospective data analysis. However, a subject’s data may be 
withdrawn from the analysis if it is subsequently discovered that the inclusion of a subject does 
not comply with the selection criteria. 
8.0 Statistics 
8.1 
Sample Size Justification 
This analysis only includes retrospective clinical data. All data from subjects fulfilling the inclusion 
criteria will be included.  
8.2 
Statistical Design & Data Analysis 
8.2.1 Analytical procedures 
Data will be analyzed using descriptive statistics and further analyses might be performed using 
applicable parametric or nonparametric methods, depending on the number of available 
datasets. 
The study plans to screen up to 50 patients. Among these 50 potential subjects, based on the 
estimation of patients who provided informed consent and who fulfill the inclusion criteria, the 
size of the included population is estimated to be around 30 to 40 subjects. 
8.2.2 Primary efficacy hypothesis 
The primary efficacy hypothesis is based on the total number of subjects n and score (percentage 
of words correctly understood) in the Freiburger Monosyllabic Word Test twelve months after 
the first fitting.  
Thus, the primary efficacy hypothesis is: 
∑(𝑊𝑜𝑟𝑑 𝑆𝑐𝑜𝑟𝑒 12 𝑚𝑜𝑛𝑡ℎ𝑠)
𝑁
> 30%  
With: 
Word Score 12 months = % of words correctly recognized at 12 months after the first fitting 

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N = number of datasets 
8.2.3 Secondary efficacy hypothesis 
The second efficacy hypothesis is based on the total number of subjects n and score (percentage 
of words correctly understood) in the HSM sentence test in quiet and in noise one year post 
activation.   
Thus, the secondary efficacy hypothesis is: 
∑(𝐻𝑆𝑀 𝑆𝑐𝑜𝑟𝑒 12 𝑚𝑜𝑛𝑡ℎ𝑠)
𝑁
> 40%  
With: 
HSM Score 12 months = % of correct sentence recognized at 12 months in quiet and in noise after 
the first fitting 
N = number of datasets  
 Pass/fail criteria to be applied to the results of the clinical investigation 
The primary efficacy hypothesis needs to be fulfilled in order to consider this investigation 
successful. 
 Procedure for reporting any deviation(s) from the original statistical plan 
In case of a deviation from the statistical plan, the final report will highlight and justify the 
deviations. 
 Minimum and maximum number of subjects to be included for each center in 
multicenter clinical investigations 
This section is not applicable. The study is a monocentric study. 
9.0 Adverse Events and Device Deficiencies 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury or any 
untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other 
persons, whether or not related to the investigational medical device and whether anticipated 
or unanticipated. This definition includes events related to the investigational medical device or 
the comparator. This definition includes events related to the procedures involved. For users or 
other persons, this definition is restricted to events related to the use of investigational medical 
devices or comparator.  
A Serious Adverse Event (SAE) is an adverse event that led to any of the following:  
a) death  
b) serious deterioration in the health of the subject, users, or other persons as defined by one or 
more of the following:  
1) life-threatening illness or injury, or 
2) permanent impairment of a body structure or a body function including chronic 
diseases, or  

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3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury, or 
permanent impairment to a body structure or a body function, 
c) foetal distress, foetal death, a congenital abnormality, or birth defect including physical or 
mental impairment. 
 
Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, without 
serious deterioration in health, is not considered a serious adverse event. 
Adverse event and device deficiencies will not be collected during this investigation. 
This retrospective data analysis is conducted for PMCF purpose as required following the devices 
clinical evaluation. The need for additional performance data specific to EAS user was identified. 
The clinical evaluation of device under investigation concludes that devices under investigation 
are safe: 
“All risks from the risk analysis are minimized, acceptable when balanced with benefits, and 
consistent with a high level of health and safety protection. All risk mitigations related to the 
clinical evaluation are sufficient since no new risk nor emergent risk have been identified. Limited 
safety issues related to the use of the Naida CI sound processors and accessories were reported 
in the included clinical datasets. These safety issues are consistent with those retrieved from 
literature, including State-of-the-Art, and those observed in PMCF activities. 
Safety issues related to external CI components are rare and within an acceptable rate as 
observed in the Clinical Evaluation Report (<5%). The majority of CI-related safety issues stem 
from the implantation surgery or the internal device.” 
 
Therefore, this investigation focuses only on performance aspects and no safety data will be 
collected. 
10.0 
Informed Consent Process 
When patients are being treated, the expert center informs them that their medical data can be 
used for any research purposes. Patients either accept or refuse. Therefore, only data for which 
subjects have given their consent may be collected as part of the clinical investigation. There will 
be no specific inform consent for this clinical investigation.  
11.0 
Vulnerable Population 
In this analysis, there is no restriction of age in the inclusion criteria. Children below the age of 
18 years are considered as vulnerable subjects. Considering the retrospective observational 
design of this investigation, there is no additional nor specific risk that might be encountered in 
this vulnerable population. Enrollment of children is justified in order to collect data reflecting 
the pediatric population. 
 
The cochlear implant works in the same way whatever the person’s age, gender and her status 
(pregnant women, breast-feeding women, etc.). Cochlear implantation does not change the way 

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people are cared for regarding any other condition. The addition of cochlear implants in these 
populations has already been carried out, as this is a retrospective observational study. 
12.0 
Benefits and Risks 
12.1 Risks associated with participation in the clinical investigation 
As explained in section 5, a retrospective observational study design with anonymization of 
clinical data was chosen for this analysis to minimize risk and effort for subjects.  
Analyses of the data do not have an influence on clinical routine and therefore do not impose 
any additional risk on the subject. Therefore, there are no specific risks related to the 
participation to this study. 
12.2 Anticipated clinical benefits  
The benefits will be the same for both Naída CI Q and Naída CI M sound processor recipients 
considering that the Acoustic Earhook for both sound processor are the same. The benefit of the 
study is the combined electrical and acoustic stimulation, which restores hearing in both silence 
and noise resulting in overall and hearing-specific improvement of quality of life.  
 
The Intended Clinical Benefit of the sound processors and acoustic earhook as part of the 
HiResolution Bionic Ear System is to provide combined electrical and acoustic stimulation to 
restore hearing in silence and in noise when sound processors are enabled with the Acoustic 
Earhook. 
The clinical benefits can be measured as follows:  
For adults 
- 
Word recognition score in quiet higher than or equal to 30% at a minimum of 12 months 
follow-up OR improvement higher than 30% compared to pre-operative stage. 
AND/OR 
- 
Sentence recognition score in quiet higher than or equal to 40% at a minimum of 12 
months follow-up OR improvement higher than 40% compared to pre-operative stage. 
For children: 
Before 4 years old: auditory awareness higher than 50% at a minimum of 12 months follow-up. 
Above 4 years old: word/sentence recognition in quiet higher than 30% or improvement of 30% 
at a minimum of 12 months follow-up. 
12.3 Anticipated adverse device effects, residuals risks and possible 
interactions with concomitant medical treatments 
The risks are similar for the two sound processors and associated acoustic earhooks under 
investigation. There are no specific risks related to the participation to this investigation as this 
is a retrospective observational data analysis in which data are already collected according to the 
center clinical care routine. 
Residual risks and potential side-effects are listed in Table 4. 

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Users of the Naída CI Q & Naída CI M sound processors and associated acoustic earhook in the 
European Union should report any serious incident to their local competent authority and to 
Advanced Bionics. 
12.4 Benefit-risk ratio  
This retrospective observational study does not impose any additional risk on the patients or 
their data, as there are no additional procedures. According to the risk analysis, risks are 
mitigated by design, inspections and tests of each specific implant and training. All risks have 
been reduced to the greatest extent possible and is available on request. The overall residual risk 
remains acceptable when weighed against the benefit of providing sound and speech perception 
to patients with severe to profound sensorineural hearing loss. This retrospective observational 
study does not impose any additional risk on the patients or their data. 
13.0 
Suspension or Premature Termination 
Not applicable, this is a single-center observational study is based on a retrospective analysis of 
anonymized clinical data with no additional procedures. Data are already collected and only 
analysis of the data, and writing of the report are necessary. 
14.0 
Monitoring, Device Accountability and Data Management 
14.1 Monitoring Procedures 
As this study is a retrospective observational study with anonymized clinical data on a CE-marked 
device without additional procedures for the subjects, the monitoring of this study is included in 
the conventional monitoring of patients during routine care by the hospital center.  
Only anonymized data will be provided to AB, preventing the possibility to verify source data. 
Therefore, no monitoring will be performed for this investigation. 
In order to ensure the validity of the transmitted data, a contract will be drawn up between the 
centre and AB with the aim of defining roles and responsibilities. The center will be responsible 
for the verification of the validity of the data. 
14.2 Device Accountability  
This is a retrospective observational study on data already collected. The devices under 
investigation are CE-marked and available on the market and were provided to the patient 
through standard distribution channels. Therefore, there is no device accountability in this study. 
14.3 Data Management Procedures / Case Report Forms 
As this is a retrospective observational study, the data were collected from the center database 
(MHH in Hanover, Germany), therefore, there are no Case Report Forms (CRF). Data source 
documents are the medical files of the patients, as filled in the center database. 
The MHH will provide anonymized clinical data in the form of a spreadsheet including speech 
performance tests data and demographic data.  
 

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Details of the data collected are presented in the following list. 
- 
Consent 
- 
Demographics:  
o Native language 
o Age at implantation 
o Gender 
o Etiology 
o Implant (type, date, side) 
o Hearing aid (start right, end right, start left, end left) 
o Hearing impairment (right, left) 
- 
Speech performance: 
o Freiburger Monosyllables (quiet) at 6 months, 1 year, 2 years, 3 years, 4 years and 
5 years after first fitting with the acoustic earhook as available 
o HSM and/or OIsa (quiet) at 6 months, 1 year, 2 years, 3 years, 4 years and 5 years 
after first fitting with the acoustic earhook as available  
o HSM in noise (55dB SPL (SNR of +10dB)) and/or OIsa in noise (50% SRT with a 65dB 
noise signal) at 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after first 
fitting with the acoustic earhook as available  
14.4 Procedures used for data review, database cleaning, and issuing and 
resolving data queries 
Retrospective anonymized data exported from the clinical patient database will be made 
available to AB in a spreadsheet format. The investigator ensures data integrity as providing 
anonymized data does not allow for data monitoring on behalf of AB.  
14.5 Procedures for verification, validation and securing of electronic clinical 
data system (if applicable) 
This section does not apply, as no data collection form (CRF) is used. 
14.6 Procedures to maintain and protect subject privacy 
There are no specific procedures required to maintain and protect the confidentiality of subjects 
as the data collected are anonymized clinical data. 
14.7 Procedures for data retention 
Only retrospective data analyses of clinical data are included in this investigation. For the clinical 
data from the center, retention procedures from the hospital apply. Data will be presented and 
analyzed in a report as well as in the Post-Market Clinical Follow-up report.  
14.8 Specified retention period 
There is no specific retention period for the data collected in this study. Once the report is 
finalized, the spreadsheet data provided by the center will be deleted. 

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14.9 Other aspects of clinical quality assurance, as appropriate 
The investigator will assure proper implementation and conduct of the data selection, 
compilation and anonymization. 
15.0 
Statements of Compliance 
This clinical investigation is conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki. 
This clinical investigation is conducted in compliance with ISO 14155:2020, the European Medical 
Device 
Regulation 
(MDR 
EU 
2017/745) 
and 
the 
German 
Medical 
Device 
law 
(Medizinprodukterecht-Durchführungsgesetz-MPDG). However, as far as only anonymized data 
will be provided to AB, preventing the possibility to verify source data, no monitoring will be 
performed for this investigation.  
Moreover, in compliance with MHH ethics committee requirements, ethical approval is not 
mandatory in the case of a retrospective data analysis of anonymized data.  
Since all devices are market approved and used according to the approved indication there is no 
study specific insurance required according to any regional or local regulation. 
16.0 
Amendments and Deviations 
16.1 Description of the procedures to amend the CIP 
The protocol must be followed exactly. Any changes to the protocol must be implemented 
through a formal protocol amendment. An amendment cannot be initiated until it has been 
approved in writing by the Sponsor, the Investigator, and the EC, as applicable. Administrative 
changes that do not affect the subject risk ratio may be made after consulting AB AG.  
16.2 Deviations 
The investigator must agree that the study will be conducted according to this CIP, the principles 
of the Declaration of Helsinki, the standard ISO 14155:2020, and local regulations, as applicable. 
Any deviation that affects the scientific soundness of the study or any aspect of the subject’s 
safety, rights or wellbeing may be a cause to close the study at the investigational center. In 
addition, these deviations will require urgent reporting to EC, as applicable. 
Amendments and deviations from this protocol will be discussed in the study report. 
17.0 
Publication Policy 
No publication of the results from this study is planned. 
18.0 
Bibliography 

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Hey et al., 2014, Investigation of a matrix sentence test in noise: Reproducibility and 
discrimination 
function 
in 
cochlear 
implant 
patients, International 
Journal 
of 
Audiology, 53:12, 895-902, DOI: 10.3109/14992027.2014.938368 
 
Winkler et al., 2016, Test-Retest-Reliabilität des Freiburger Einsilbertests [Test-retest reliability 
of the Freiburg monosyllabic speech test]. HNO. Aug;64(8):564-71. German. DOI: 
10.1007/s00106-016-0166-2. 
 
Kollmeier et al., 2015. The multilingual matrix test: Principles, applications, and comparison 
across languages: A review. Int J Audiol. ;54 Suppl 2:3-16. DOI: 10.3109/14992027.2015.1020971.  
19.0 
Study Sites, Investigators and External Organizations 
19.1 Study Sites and Investigators 
Prof. Andreas Büchner 
Scientific Director 
Medizinische Hochschule Hannover (MHH) 
Deutsches Hörzentrum Hannover (DHZ) 
Karl-Wiechert-Allee 3 
30625 Hannover 
Germany 
19.2 External Organizations 
Not applicable 
20.0 
Revision History (if applicable) 
This is the first version of the CIP. 
 
 
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CIP Sponsor Signature Page 
 
Gunnar 
Geissler, 
Research 
Audiologist, 
Advanced Bionics, Hannover 
 
 
 
 
 
Date: 
 
Signature: 
 
Jenny Goldring, Regulatory Affairs Manager, 
Advanced Bionics, Valencia 
 
 
 
 
Date: 
 
Signature: 
 
Laure 
Arnold, 
Senior 
Director 
Clinical 
Research, Advanced Bionics, Hannover 
 
 
 
 
Date: 
 
Signature: 
 
 
Volkmar Hamacher, Global VP Research & 
Technology and Clinical Affairs, Advanced 
Bionics, Hannover 
 
 
 
 
 
Date: 
 
Signature: 
 
 
Martjin Deiters, Head of Finance/Controlling 
for AB International & MD AB AG Switzerland, 
Stafa: 
 
 
 
 
 
Date: 
 
Signature: 
 
 
 
 
 
1/21/2024
1/19/2024
1/19/2024
1/19/2024
1/19/2024
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CIP Investigator Signature Page 
 
I, the undersigned, have read and understand the protocol specified above and agree on its content. I 
agree to perform and conduct the study as described in the protocol and in accordance with the relevant 
parts of the ICH Guidelines for GCP, ISO 14155:2020, and MDR (EU) 2017/745, the Declaration of Helsinki, 
and the pertinent individual country laws/regulations applicable in Germany.  
In addition, I assume responsibility for protocol compliance for persons to whom I delegate study related 
tasks.  
 
Prof. Andreas Büchner, Scientific Director, 
Medizinische Hochschule Hannover, Hannover 
 
Date: 
 
Signature: 
 
 
 
 
 
 
1/22/2024
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