Ambispective Clinical Evaluation of Sophono™
Conditions: Conductive Hearing Loss, Single-Sided Deafness, Mixed Hearing Loss
Sponsor: Medtronic Surgical Technologies

 
 
 
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Clinical Investigation Plan  
 
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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  Ambispective Clinical Evaluation of Sophono™ 
(ACES) 
Clinical Investigation Plan Identifier 
 
Study Product Name Sophono Alpha 2 and Alpha 2 MPO Systems 
Sponsor/Local Sponsor Medtronic Xomed, Inc. 
6743 Southpoint Dr North 
Jacksonville, FL 32216 
Telephone: (904) 296-9600 
Document Version 
 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic. Any 
distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly 
prohibited. Persons to whom the information is disclosed must know that it is confidential and that it may 
not be further disclosed by them. 
 
 

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Version 
Summary of Changes 
Author(s)/Title 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 

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2. Investigator Statement 
Study product Name Ambispecitve Clinical Evaluation of Sophono™ (ACES) 
Sponsor 
 Medtronic Xomed, Inc.  
6743 Southpoint Dr North  
Jacksonville, FL 32216  
Telephone: (904) 296-9600  
Clinical Investigation Plan Identifier 
 
Version Number/Date  
17Jul2017 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for me 
and my staff to conduct this study as described. I will conduct this study as outlined herein and will make 
a reasonable effort to complete the study within the time designated. 
I agree to comply with International Conference on Harmonization Guidelines on Good Clinical Practice. I 
agree to ensure that the confidential information contained in this document will not be used for any 
purpose other than the evaluation and conduct of the clinical investigation without the prior written 
consent of Medtronic. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
Investigator’s Signature:  
Investigator’s Name:  
Institution:  
Date:   
 
 

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Table of Contents  
 
1. 
Version History ........................................................................................ 2 
2. 
Investigator Statement ........................................................................... 3 
3. 
Glossary ................................................................................................... 6 
4. 
Synopsis .................................................................................................. 9 
5. 
Introduction .......................................................................................... 13 
5.1. 
Background ........................................................................................................ 13 
5.2. 
Purpose .............................................................................................................. 14 
6. 
Objectives and Endpoints ...................................................................... 14 
6.1. 
Objectives .......................................................................................................... 14 
6.1.1. Primary Objectives ........................................................................................... 14 
6.1.2. Secondary Objectives ....................................................................................... 14 
6.2. 
Endpoints ........................................................................................................... 15 
6.2.1. Primary Endpoint ............................................................................................. 15 
6.2.1.1. 
Primary Safety Endpoint ................................................................................ 15 
6.2.1.2. 
Primary Efficacy Endpoint .............................................................................. 15 
6.2.2. Secondary Endpoints ........................................................................................ 15 
6.2.3. Other Endpoints ............................................................................................... 15 
7. 
Study Design ......................................................................................... 16 
7.1. 
Duration ............................................................................................................. 16 
7.2. 
Rationale ............................................................................................................ 16 
8. 
Product Description ............................................................................... 16 
8.1. 
General .............................................................................................................. 16 
8.1.1. Magnetic Implant ............................................................................................. 17 
8.1.2. Magnetic Spacer .............................................................................................. 18 
8.1.3. Sound Processors ............................................................................................. 18 
8.2. 
Manufacturer ...................................................................................................... 19 
8.3. 
Intended Population ............................................................................................ 19 
8.4. 
Equipment .......................................................................................................... 19 
8.5. 
Product Use ........................................................................................................ 19 
8.6. 
Product Training Requirements ............................................................................ 19 
8.7. 
Product Receipt and Tracking .............................................................................. 19 
8.8. 
Product Storage .................................................................................................. 20 
8.9. 
Product Return ................................................................................................... 20 
8.10. 
Product Accountability ......................................................................................... 20 
9. 
Selection of Subjects ............................................................................. 21 
9.1. 
Study Population ................................................................................................. 21 
9.2. 
Subject Enrollment .............................................................................................. 21 

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9.3. 
Inclusion Criteria ................................................................................................. 21 
9.4. 
Exclusion Criteria ................................................................................................ 22 
10. Study Procedures................................................................................... 22 
10.1. 
Schedule of Events .............................................................................................. 22 
10.2. 
Subject Screening ............................................................................................... 26 
10.3. 
Prior and Concomitant Medications ...................................................................... 26 
10.4. 
Subject Consent .................................................................................................. 26 
10.5. 
Randomization and Treatment Assignment ........................................................... 26 
10.6. 
Assessment of Safety .......................................................................................... 27 
10.7. 
Recording Data ................................................................................................... 27 
10.8. 
Deviation Handling .............................................................................................. 27 
10.9. 
Subject Withdrawal or Discontinuation ................................................................. 28 
11. Risks and Benefits ................................................................................. 28 
11.1. 
Potential Risks .................................................................................................... 28 
11.2. 
Potential Benefits ................................................................................................ 28 
11.3. 
Risk-Benefit Rationale ......................................................................................... 28 
12. Adverse Event Assessments .................................................................. 29 
12.1. 
Definitions/Classifications .................................................................................... 29 
12.1.1. 
Classification of adverse events ..................................................................... 30 
12.2. 
Reporting of Adverse Events ................................................................................ 34 
13. Statistical Design and Methods ............................................................. 35 
13.1. 
Sample size ........................................................................................................ 35 
13.2. 
Data analysis and reporting ................................................................................. 35 
13.3. 
Safety endpoint .................................................................................................. 36 
13.4. 
Effectiveness endpoint......................................................................................... 37 
14. Ethics ..................................................................................................... 37 
14.1. 
Statement(s) of Compliance ................................................................................. 37 
15. Study Administration ............................................................................. 38 
15.1. 
Monitoring .......................................................................................................... 38 
15.2. 
Data Management ............................................................................................... 38 
15.3. 
Direct Access to Source Data/Documents ............................................................. 39 
15.4. 
Confidentiality ..................................................................................................... 39 
15.5. 
CIP Amendments ................................................................................................ 39 
15.6. 
Record Retention ................................................................................................ 39 
15.6.1. 
Sponsor Requirements .................................................................................. 40 
15.6.2. 
Investigational Site Requirements .................................................................. 40 
15.7. 
Publication and Use of Information ...................................................................... 41 
15.8. 
Suspension or Early Termination .......................................................................... 41 
16. References ............................................................................................. 42 
17. Appendices ............................................................................................ 47 
 

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3. Glossary 
Term 
Definition 
AE 
Adverse Event  
AC 
Air Conduction 
ACES 
Ambispective Clinical Evaluation of Sophono 
ADE 
Adverse Device Effect 
Ambispective 
Inclusion of both retrospective and prospective 
components 
ANSI 
American National Standards Institute 
APHAB 
Abbreviated Profile of Hearing Aid Benefit 
BAHA 
Bone Anchored Hearing Aid 
BC 
Bone Conduction 
BKB-SIN 
Bamford-Kowal-Bench Speech-In-Noise 
CFR 
Code of Federal Regulations 
CHL 
Conductive Hearing Loss  
CRF 
Case Report Form 
CROS 
Contralateral Routing Of Signal  
CSF 
Cerebrospinal Fluid 

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Term 
Definition 
dB 
Decibel 
DSP 
Digital Signal Processing 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
ENT 
Ear, Nose and Throat 
GCP 
Good Clinical Practice 
HL 
Hearing Loss 
Hz 
Hertz 
IC 
Informed Consent  
IRB/IEC 
Institutional Review Board/Institutional Ethics 
Committee 
MDR 
Medical Device Reporting System 
MPO 
Maximum Power Output 
MRI 
Magnetic Resonance Imaging 
PTA 
Pure Tone Average 
SNR 
Signal-to-Noise Ratio 
SRT 
Speech Recognition Threshold 
SSD 
Single-Sided Deafness 
QOL 
Quality of Life 

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Term 
Definition 
USADE 
Unanticipated Serious Adverse Device Effect 
 
 
 

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4. Synopsis 
Clinical Study Type Post-market (Ambispective) 
Sponsor  Medtronic Xomed, Inc. 
6743 Southpoint Dr North 
Jacksonville, FL 32216 
Telephone: (904) 296-9600 
Indication under 
investigation  
There is no indication under investigation; this is a post-market study. 
Below is the currently cleared indication for use: 
The Otomag™ Alpha 2 Sound Processor is intended for use with the 
Otomag Headband or Otomag Softband (no age limitations), or with the 
Otomag Magnetic Implant (patients 5 years of age and up) for the 
following patients and indications: 
• 
Patients with conductive or mixed hearing losses, who can still 
benefit from amplification of sound.  The pure tone average (PTA) 
bone conduction (BC) threshold for the indicated ear should be better 
than 45 dB hearing loss (HL) (measured at 500, 1000, 2000, and 
3000 Hz).  
• 
Bilateral fitting is applicable for most patients having a symmetrically 
conductive or mixed HL.  The difference between the left and right 
sides’ BC thresholds should be less than 10 dB on average measured 
at 500, 1000, 2000, and 4000 Hz, or less than 15 dB at individual 
frequencies.  
• 
Patients who have a profound sensorineural hearing loss in one ear 
and normal hearing in the opposite ear, who for some reason will not 
or cannot use air conduction (AC) Contralateral Routing of Signal 
(CROS).  The PTA AC threshold of the hearing ear should be better 
than 20 dB HL (measured at 500, 1000, 2000 and 3000 Hz). 
Investigation Purpose Accumulate post-market clinical evidence for the safety and effectiveness 
of the Sophono Alpha 2 Maximum Power Output (MPO) systems. 

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Product Status Cleared for use in the geography where study is being conducted (USA). 
Primary Objective(s) The primary objectives of this study are to  
• 
Assess the safety of the Sophono implant    
• 
Assess the effectiveness of the Sophono Alpha 2 MPO processor 
Secondary Objective(s) The secondary objectives of this study are to  
• 
Compare the effectiveness of the Sophono Alpha 2 processor to the 
Alpha 2 MPO processor  
• 
Assess the effectiveness of the Sophono Alpha 2 and the Sophono 
Alpha 2 MPO over time 
• 
Assess subject satisfaction after system use 
• 
Assess Quality of Life (QOL) after system use 
Study Design Ambispective, multi-center, single-blind, intra-subject controlled study to 
assess safety of the Sophono implant and effectiveness of the Sophono 
processors in subjects with single-sided deafness (SSD), conductive 
hearing loss (CHL), and mixed HL. 
Subject population:  
Any subject who currently has or who has had the 
Sophono implant (including those who have been 
explanted) 
Follow-up schedule: 
A clinic visit to evaluate the subject and collect 
self-assessments. 
Study Population Males and females who meet study criteria will be included in the study. 
Subjects are expected to represent those diagnosed with CHL, SSD and 
mixed HL. Subjects will be recruited by Investigators who have implanted 
the Sophono system.   
Sample Size ~100 subjects at up to 15 investigational sites in the US 
Inclusion/Exclusion 
Criteria 
Inclusion Criteria 
• 
Any subject who currently has or who has had the Sophono implant 
(including those who have been explanted) 
• 
Has or has had Sophono implant for 3 months or greater 

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Exclusion Criteria 
• 
Subject has implant but is unable or unwilling to perform audiologic 
testing 
• 
Subject is currently participating in another clinical study and has not 
been approved for concurrent enrollment by the Study Sponsor 
Study Procedures and 
Assessments 
After proper administration and signing of the Informed Consent (IC) and 
Research Authorization Forms, all potential subjects will be assessed for 
study eligibility based on the Inclusion and Exclusion Criteria.  
Retrospective data collection from medical charts for safety and baseline 
data will be collected by the site. 
Prospective Data Collection (visit): 
• 
ENT visit 
• 
Examination of implanted ear 
• 
Satisfaction Questions 
• 
QOL questions: Abbreviated Profile of Hearing Aid Benefit 
(APHAB)™  Version A 
 
• 
Audiologist Visit: Optimization of device programming for all aided 
tests should be completed. 
• 
Hearing in Noise Test: BKB-SIN 
• 
Speech and Language Tests: Word Recognition Score, Speech 
Reception Threshold 
• 
Audiograms: 
• 
Baseline AC Thresholds at octave intervals at 250, 500, 
1000, 2000, 3000, 4000 and 8000 Hz 
• 
Test Baseline BC and Aided Thresholds at 500, 1000, 
2000, 3000 and 4000 Hz 
• 
Subjects are blinded to processor types for all tests 
 
 
 

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Audiogram Test Design 
Tests 
Subject has Alpha 1, Alpha 2, or Alpha 2 
MPO Processor* 
Test 1 
No processor 
Test 2 
Alpha 2 
Test 3 
Alpha 2 MPO 
*Alpha 2 and Alpha 2 MPO processors will be provided to each site for use 
in the study. Thus, regardless of the processor the subject wears daily, 
both Alpha2 and Alpha 2 MPO can be tested on each subject. 
Safety Assessments A review and assessment of all device-related Adverse Events (AE) 
collected retrospectively via chart review, and any prospective device-
related AE that occur from the time of subject consent until the time of 
study exit. 
 Statistics The primary effectiveness endpoints are the improvement in aided hearing 
from unaided hearing by the Sophono Alpha 2 MPO processor. This 
endpoint will be summarized by means of paired (samples) t-test or 
Wilcoxon signed rank sum test according to the normal or non-normal 
distribution as appropriate. 
The primary safety endpoint is an assessment of all AEs (prospective or 
retrospective) that are directly attributable to the Sophono device (implant 
or processor). This endpoint will be the proportion of events reported with 
confidence interval (95%).  
 
 
 

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5. Introduction  
5.1. 
Background 
Over the past three decades, bone-anchored hearing devices have become increasingly popular for the 
restoration of various types of hearing loss (HL) in the adult and pediatric populations. Though the idea 
of bone-conduction for sound amplification has been known and studied since the Renaissance, the 
concept of a device fully implanted within bone was not developed until the 1970s.(1) 
Percutaneous devices have been successfully used to treat conductive hearing loss (CHL) both in adult 
and in pediatric patients.(2–4)  Percutaneous devices have the advantage of direct transmission of 
vibrations through the bone, thus providing optimal hearing gain; however, their drawbacks include the 
need for osseointegration, risk of local infection, soft tissue overgrowth and poor aesthetic outcome. 
It has been demonstrated that children with these percutaneous implants are more prone to adverse 
events (AEs) (e.g. skin reactions and [traumatic] implant loss) compared with adults.(5–7)  Recent data 
show that children experience adverse skin reactions in 7.8% of the implant cases, and 15.2% of these 
percutaneous implants are lost in children.(8) 
Therefore, a device system that provides bone conduction (BC) hearing while the skin remains intact is 
ideal and such transcutaneous devices (e.g. Sophono Alpha 2 and Alpha 2 Maximum Power Output 
(MPO)) are currently the subject of new research and optimization. 
In 1986, Hough et al. (9) introduced the first transcutaneous concept, the Temporal Bone Stimulator, 
also termed the Xomed-Audiant device (Audiant). This device system contained a permanent magnet that 
was implanted in the temporal bone and covered by a thin layer of skin. Sound vibrations were 
transferred transcutaneously by an external coil that was positioned on the skin to the implanted magnet. 
Consequently, the implanted magnet was part of the actuator of the Audiant device. The external coil 
was powered by an amplifier in a behind-the-ear housing or in a larger, bodyworn housing. The major 
disadvantage of this configuration was the relatively wide distance between the implanted magnet and 
the external driving coil (10); resultantly, gain and maximum output were low (11) and significantly 
worse compared with that of the percutaneous alternative.(10) Additionally, the clinical outcomes of the 
Audiant were less favorable (12), and the device was withdrawn from the market. 
In 2005, Siegert developed the Otomag BC hearing device, a transcutaneous BC implant that uses dual 
magnets implanted snugly onto the temporal bone with five screws.  The sound processor attaches to the 
skin with a magnetic base plate that is available in a variety of strengths to provide options for 

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attachment strength. Siegert reported no major complications in over 100 patients related to implantation 
and only minor skin reactions which resolved after adjusting the forces of the magnets.(13,14) 
The Otomag device was purchased by Sophono in 2010 and became commercially known as the Sophono 
Alpha 1 System;  the system has gone through a series of upgrades to the sound processor (Alpha 2 and 
Alpha 2 MPO) while the implant with dual magnets remains relatively unchanged since the inception 
(note: Otomag will hereafter be referred to as “Sophono™”).  Bench audiogram research and ancillary 
data presented at society meetings indicate an improved feedback free gain from the Alpha 2 MPO 
device; however, to date no studies have been published.  The Sophono Company was acquired by 
Medtronic in 2015.  
The aim of this study is to examine the long-term (implant duration three months or longer) audiologic, 
safety, and quality of life (QOL) outcomes of subjects implanted with the Sophono bone conduction 
hearing implant and to compare the Alpha 2 to the Alpha 2 MPO. 
5.2. 
Purpose 
Accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and 
Alpha 2 MPO systems. 
6. Objectives and Endpoints 
6.1. 
Objectives 
6.1.1. 
Primary Objectives 
The primary objectives of this study are to  
• 
Assess the safety of the Sophono implant  
• 
Assess the effectiveness of the Sophono Alpha 2 MPO processor  
in subjects diagnosed with CHL, SSD and mixed HL who currently has or has had the Sophono implant. 
6.1.2. 
Secondary Objectives  
The secondary objectives of this study are to 
• 
Compare the effectiveness of the Sophono Alpha 2 processor to the Alpha 2 MPO processor 

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• 
Assess the effectiveness of the Sophono Alpha 2 and the Sophono Alpha 2 MPO over time 
• 
Assess subject satisfaction after system use 
• 
Assess QOL after system use 
in subjects diagnosed with CHL, SSD and mixed HL who currently has or has had the Sophono implant. 
6.2. 
Endpoints 
6.2.1. 
Primary Endpoint 
6.2.1.1. 
Primary Safety Endpoint 
The primary safety endpoint is the proportion of AEs related to the Sophono implant, which will be 
assessed through retrospective surgical chart review and prospective ENT exam. 
6.2.1.2. 
Primary Efficacy Endpoint 
The primary efficacy endpoint is the difference (gain) in the free-field pure tone audiometry assessed by 
pure tone average (PTA) unaided (AC) and aided (BC) by the Alpha 2 MPO processor.  
6.2.2. 
Secondary Endpoints 
The secondary endpoints include:  
• 
The difference in the free-field pure tone audiometry assessed by PTA aided by Alpha 2 processor 
compared to the PTA aided by Alpha 2 MPO processor 
• 
Change over time of PTA in the Sophono Alpha 2 and Alpha 2 MPO  
• 
Subject satisfaction, via non-validated satisfaction questions and QOL assessment through validated 
Abbreviated Profile of Hearing Aid Benefit (APHAB)™ assessment 
6.2.3. 
Other Endpoints 
Other endpoints include: 
• 
Change over time in speech reception threshold scores in the Sophono Alpha 2 and Alpha 2 MPO  
• 
Change over time in word recognition scores in the Sophono Alpha 2 and Alpha 2 MPO  
 

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7. Study Design  
This study is an ambispective, multi-center, single-blind, intra-subject controlled study to assess safety of 
the Sophono implant and effectiveness of the Sophono Alpha 2 MPO processor in subjects with single-
sided deafness (SSD), CHL, and mixed HL.  This study will enroll approximately 100 subjects (with 
unilateral or bilateral implants) at up to 15 investigational sites in the US.  (Investigational sites may 
include separate Audiology Centers, if applicable). 
 
The subject population includes any patient who currently has or has had the Sophono implant, including 
those patients who have been explanted.  
 
The study will consist of a retrospective medical chart review to collect data on AEs for all subjects upon 
receiving informed consent.  A prospective clinic visit for subjects still implanted with the Sophono 
implant will be conducted to evaluate the subject’s implant site and conduct hearing tests, along with a 
QOL and satisfaction self-assessment. 
7.1. 
Duration 
It is anticipated this study will conclude within 15 months of enrollment of the first subject.  This 
estimation is based on the following assumptions:  12 months for subject enrollment/participation, 3 
months for data cleaning, analysis, and final report. 
7.2. 
Rationale  
This study is being conducted to provide an expanded data portfolio of the post-market safety and 
performance of the Sophono Alpha 2 MPO system.
 
 
8. Product Description 
8.1. 
General 
The Sophono Bone Conduction Hearing Systems are a family of sound processors and accessories that 
operate on the principle of BC of sound vibrations.  The Sophono Bone Conduction Hearing Systems 

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transmits audio vibrations through the skin into the bone where sound is sensed by the inner 
ear/cochlea. 
The Sophono Sound Processor is magnetically attracted to the Magnetic Implant and Magnetic Spacer.  
The Magnetic Implant, which is secured to the skull bone, affixes the Magnetic Spacer to the head 
transcutaneously through magnetic attraction forces, and the Sound Processor is magnetically affixed to 
the Magnetic Spacer.  Vibration from the Sound Processor is transduced through the Magnetic Spacer to 
the Magnetic Implant and through the bone to the inner ear.  
 
Figure 1 Sophono Bone Conduction Hearing System 
 
The Magnetic Implant is the same size and configuration for all subjects, regardless of the processor.  
The Attract® Magnetic Spacer comes in various strengths.  The appropriate strength for daily wear is 
recommended by the Audiologist at the time of processor optimization. The results of the hearing tests 
with these magnets are out of scope of this study.  
8.1.1. 
Magnetic Implant 
The Sophono Magnetic Implant is comprised of 
 
  The implant casing is designed to use 5 craniomaxillofacial screws to secure 

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it to the bone.  The implant provides magnetic retention through the skin to a magnetic spacer, which in 
turn holds the audio processor. 
8.1.2. 
Magnetic Spacer 
The Sophono Magnetic Spacer is an externally worn component that magnetically couples the Sophono 
Sound processor to the Sophono magnetic implant. The Magnetic Spacers also contain
 
  Spacers are available 
in a range of magnetic strengths. They are labeled with “dots” to note the magnetic strength (1-dot 
represents a lower magnetic strength; 5-dots represent a higher magnetic strength). The strength is also 
indicated by the first digit in the engraved numbers (as shown in Figure 1). Typically a processor is 
shipped with five spacers (dots 1 through 5). Other spacers (both weaker and stronger) are also 
available. 
8.1.3. 
Sound Processors 
The Sophono Processor is an audio processor that converts sound into mechanical vibrations. Sound 
enters the audio processor through the microphones, which then goes through 
 
 
 
he vibrations are carried through the patient’s skin and skull to the cochlea where 
they are perceived as sound.  The Sophono Sound Processors have a simple user interface with a 
combined  on/off  and volume switch wheel, and a push button switch that allows the user to swap 
between four programmable settings configured by the clinician during the fitting session. 
Table 1. Sophono Sound Processors 
Sophono Sound Processor 
Product Number 
Alpha 1  
S0001-XX 
Alpha 2  
S0415-XX 
Alpha 2 MPO 
S0415-XX 
Alpha 2 MPO Low Profile 
S0415-XX 

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8.2. 
Manufacturer 
Sophono, Inc. 
5744 Central Ave. #100 
Boulder, CO   80301 
8.3. 
Intended Population 
The Sophono Systems are designed for use for those patients with CHL, those patients who have 
sensorineural hearing loss up to 45 dB in combination with their CHL, and SSD as defined in the 
indications for use.  The prescriptive formula and adjustments available to the audiologist in the software 
allow for programming the Sophono Systems for individual patient HL. 
8.4. 
Equipment 
The following auditory measurement equipment is required for the subject follow-up visit:  
• 
Audiometer  
• 
BKB-SIN Hearing in Noise Test Software (provided by Sponsor) 
• 
Speech Recognition Test digital recording (provided by Sponsor) 
• 
Word Recognition NU-6 digital recording (provided by Sponsor) 
• 
Sophono Alpha 2 and Alpha 2 MPO processors (provided by Sponsor) 
8.5. 
Product Use 
The Sophono Alpha 2 and Alpha 2 MPO Processors will be used in accordance with the study design in 
Section 10.  All testing is performed according to standard audiology protocol. 
8.6. 
Product Training Requirements 
Study Investigators and Audiologists will be qualified for this study based on their experience with the 
product as currently on the market.  No additional product training is expected but will be provided upon 
request.  
8.7. 
Product Receipt and Tracking 
Alpha 2 and Alpha 2 MPO processors provided to each site will be tracked by identification number in the 
Device Accountability Log. As soon as possible after receipt, and prior to first use, the site will connect 

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the processor to the software to confirm processor response and ensure no damage was sustained during 
shipping.  Any damage to the processors will be documented. The product will be compared to the Log 
by a site representative and signed. The signed Log will be copied and faxed or scanned back to the 
Sponsor. The original will be retained at the site in the Study Binder. 
8.8. 
Product Storage 
Each participating site will receive one Alpha 2 and one Alpha 2 MPO sound processor to use as a 
comparator in the study.  These processors will be stored in a secure location at the clinical site with 
access restricted to designated study personnel only. Storage requirements should be in accordance with 
the Instructions for Use provided with the processors, sites’ operating policies, and applicable federal and 
geographic regulations. 
8.9. 
Product Return 
The Alpha 2 and Alpha 2 MPO processors provided to the sites for the study should be returned as part of 
site closure activities to Medtronic, Inc. at the following address: 
 
 
 
 
 
8.10. Product Accountability  
A Device Accountability Log will be maintained for the receipt of the Alpha 2 and Alpha 2 MPO processors 
provided to each site. Devices will only be used on subjects who have qualified for the study and have 
signed an Informed Consent (IC) and Research Authorization as part of the enrollment process. Device 
accountability is required by the site to ensure accurate and secure inventory stores. Device reconciliation 
must include receipt and final disposition and method of final allocation per device. 
 
 
 

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9. Selection of Subjects 
9.1. 
Study Population 
The subject population for this study includes male and female patients who have received the Sophono 
implant.  Subjects will be recruited from Investigators who have implanted Sophono systems or from 
other non-investigator physician referrals.  Subjects are expected to represent a population diagnosed 
with CHL, SSD, and mixed HL.   
9.2. 
Subject Enrollment 
All subjects will be screened for study eligibility. A qualified member of the investigational site’s research 
team will review the inclusion and exclusion criteria to screen each subject. Subjects will be considered 
enrolled into the study when they have both:  
• 
Been informed of the study design, objectives, risks and benefits  
• 
Confirmed interest in participation by signing an IC and Research Authorization  Forms  
A Log of subjects treated with Sophono at each site will be reviewed for eligibility criteria. Any subject 
who currently has or who has had the Sophono implant (including those who have been explanted) may 
be enrolled. This means subjects implanted outside of the intended indications may have data collected 
as part of this study. 
A Screening and Enrollment Log will be maintained for all subjects and will include information regarding 
subjects who have met the screening criteria and subjects who have not met the screening criteria 
(screen-fail). For screen-fail subjects, a reason for failure will be noted (e.g., patient declined 
participation, eligibility criterion not met, etc.). 
To be enrolled in this study, subjects must meet ALL of the inclusion criteria and NONE of the exclusion 
criteria:  
9.3. 
Inclusion Criteria 
• 
Any subject who currently has or who has had the Sophono implant (including those who have been 
explanted) 
• 
Has or has had Sophono implant for 3 months or longer 

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9.4. 
Exclusion Criteria 
• 
Subject has implant but is unable or unwilling to perform audiologic testing 
• 
Subject is currently participating in another clinical study and has not been approved for concurrent 
enrollment by the Study Sponsor 
10. Study Procedures 
Prior to enrolling subjects, the Study Investigator and associated study personnel will undergo study-
related training. All training will be documented and maintained in the study files.  
After signing the IC and Research Authorization Forms, subjects will be screened for eligibility of the 
Inclusion/Exclusion criteria, which will be documented on the Inclusion/Exclusion Criteria Case Report 
Form (CRF).   
10.1. Schedule of Events 
After proper administration and signing of the IC and Research Authorization Forms, all potential subjects 
will be assessed for study eligibility based on the Inclusion and Exclusion Criteria.  Inclusion and 
Exclusions data as well as limited demographic information will be captured in the subject CRFs. 
A retrospective review of the subject’s medical chart will be performed to gather and report data on 
subject surgical history, reportable AEs from the time of implantation to time of chart review, previous 
QOL scores, and previous audiometric testing results for Alpha 2 and/or Alpha 2 MPO processors. 
An in-office visit will be conducted with an ENT physician and Audiologist, ideally on the same day, 
where the following assessments will take place: 
ENT Visit:  
The ENT visit will consist of an examination of the ear and implant site for skin complications (according 
to the Holger Skin Evaluation Index in Table 2) or other potential AEs (see Section 12 for reportable AEs). 
The ENT Visit CRF will detail findings (such as erythema, scar, etc.) as well as complications (skin loss, 
infection, etc.). Any such complications will be recorded on an AE form.  
Sophono system satisfaction and QOL questions shall also be administered to allow the subjects’ 
perceived benefits to be assessed. The QOL assessment will be done using the APHAB Version A. 
 

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Table 2. Holger Skin Evaluation Index 
The skin directly over the implant site will be evaluated on the Holger Skin Evaluation Index. 
Holger Skin Evaluation Index 
0 = No irritation. Epithelium debris removed if present. 
1 = Slight redness, local treatment. 
2 = Red and slightly moist tissue. No granuloma formation noted. Local treatment. Extra controls. 
3 = Status as in 1 and 2 but local revision became necessary. 
4 = Removal of skin-penetrating implant necessary due to infection. 
R = Removed implant for reasons not related to skin problems. 
 
Audiology Visit: 
All audiometric testing equipment should be calibrated and tested to American National Standards 
Institute (ANSI) standards, in good repair and functioning well.  
 
All tests should be performed in the order presented in Table 3.  Subject will be blinded to 
processor order.   
 
In sound field testing the good ear should be plugged using an ear plug. The speech presented 
should be a recording. When results indicate the need for masking, effective masking should be 
presented in the non-test ear through the use of inserts or headphones using speech weighted 
noise.  Testing should be performed on the affected ear unless otherwise noted. 
 
All   audiometric   testing   shall   include   aided   and   unaided   testing since completing basic pure 
tone and speech audiometry in the unaided and aided condition allows functional gain 
measurements to be made.  
 
 

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Unaided 
1. Audiometry thresholds should be obtained for both ears at the following frequencies:  
• 
Basic Audiometry (inserts or headphones) AC: 250, 500, 1000, 2000, 3000, 4000 & 8000 Hz 
• 
BC: 500, 1000, 2000, 3000 & 4000 Hz 
 
2. Speech Reception Threshold should be conducted using spondee words.  The speech presented 
should be a recording.  
 
3. Word Recognition should be conducted using one NU-6 list for each test. The speech presented 
should be a recording. The standardized monosyllabic word list should be presented at 65 dBHL 
(Hearing Level).  
 
4. Hearing in Noise Testing (HINT) should be conducted using the BKB-SIN.  Recording is presented 
via a single loudspeaker in the sound field.  
Recorded testing should have babble and speech presented from the same speaker at 70 dBHL with 
the subject 1 meter from speaker at 0° azimuth.   
 
 
Aided 
1. Audiometry thresholds should be obtained at the following frequencies:  
• 
Aided (sound field): 500, 1000, 2000, 3000 & 4000 Hz 
Processors should start at 100% optimization and only be lowered if feedback is intolerable for 
subject. 
 
2. Speech Reception Threshold should be conducted using spondee words in the sound field. The 
speech presented should be a recording.  
 
3. Word Recognition should be conducted using one NU-6 list for each test in the sound field. The 
speech presented should be a recording. The standardized monosyllabic word list should be 
presented at 65 dBHL.  
 

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4. HINT should be conducted using the BKB-SIN. Recording is presented via a single loudspeaker in 
the sound field.  
Recorded testing should have babble and speech presented from the same speaker at 70 dBHL with 
the subject 1 meter from speaker at 0° azimuth.   
 
 
Figure 2. Study Flow Chart 
 

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10.2. Subject Screening  
Sites will have a log of all patients at their Institution who have been implanted with the Sophono 
implant, including those who have been explanted. All subjects will be contacted for interest in study 
participation and asked to sign the IC and Research Authorization Form for retrospective medical chart 
review as well as a prospective data collection visit.  Any subject’s unwillingness to participate will be 
documented in the Subject Screening/Enrollment Log.   
10.3. Prior and Concomitant Medications 
No change in medication is required for this study, nor will any additional medications be required. 
Medications will not be collected unless relevant to an AE.  
10.4. Subject Consent 
Prior to study enrollment and before any study visits are initiated, all subjects must document their 
consent by signing an IC and Research Authorization Form. The Study Investigator or his/her authorized 
designee will conduct the informed consent process during which the subject will have the opportunity to 
ask questions and receive answers about the study. Subjects will be made aware that the study includes 
a medical chart review, as well as an in-office follow-up visit, and they should be willing to comply with 
the study requirements to be available for study visits. If they decide not to come in for the in-office 
follow-up visit the data from the medical chart review will still be used in data analysis. 
 
A copy of the signed IC and Research Authorization will be provided to the subject, and the original 
signed version will be retained in the site’s study files. The site will record the date of consent in the 
CRFs.  
 
Obtaining data from a subject’s medical chart or a follow-up visit without obtaining informed consent is a 
protocol violation and is to be recorded in the Protocol Deviation CRF and reported to the Sponsor, as 
well as the respective IRB/IEC as soon as possible, but no later than five (5) working days after 
the event occurred, or sooner if required by the IRB/IEC.   
10.5. Randomization and Treatment Assignment 
There is no randomization in this study as bias is expected to be negligible.  All subjects will undergo 
testing with two (2) processors and a blank in the order given below (Table 3).  

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Table 3. Audiogram Test Design 
Tests 
Subject has Alpha 1, Alpha 2, or Alpha 2 
MPO Processor 
Test 1 
No processor  
Test 2 
Alpha 2 
Test 3 
Alpha 2 MPO 
 
10.6. Assessment of Safety 
Retrospective data collection will include the collection and recording of device and procedure-related AEs 
which occurred from the time of implant until present day. No safety reporting to IRBs will be executed 
for retrospective events.  AEs found via the retrospective chart review will be reported to Medtronic 
Product Quality Experience Group as required by regulations. 
Prospective data collection will be from the date of signed IC, and will be reported to Medtronic’s Product 
Quality Experience Group and the IRBs per Institutional reporting requirements.  
10.7. Recording Data 
Data will be recorded on electronic Case Report Forms (eCRFs) in the Electronic Data Capture (EDC) 
system, Oracle Clinical.  For the retrospective portion of the study medical charts, operative notes, and 
other medical records will be considered as the source documents.  For the prospective portion of the 
study, CRFs can be used as source for this study as well as medical charts. Source document worksheets 
will be provided to the sites if requested. 
10.8. Deviation Handling 
It is expected that the Investigator will adhere to the protocol and not deviate unless medically necessary 
in response to an emergency situation to protect the rights, safety and well-being of the subject.  
Planned deviations may be submitted to the Sponsor in advance for review and approval, as necessary.  
Protocol deviations that occur will be documented on the Protocol Deviation CRF and reported to the IRB 
based on the IRB schedule. 

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10.9. Subject Withdrawal or Discontinuation  
If a subject is consented but subsequently decides to withdraw from the study before coming in for the 
prospective data collection visit, the subject will be considered to be withdrawn from the study, and the 
reason will be captured on the Study Exit CRF.  
Subjects who are unresponsive after a minimum of 3 attempts to contact them by phone or other means 
for their prospective data collection visit will be considered lost to follow-up. The types of attempts 
(phone, email, text, mail) will also be captured on the Study Exit CRF. Note: retrospective safety data 
collected may still be used in the study. 
11. Risks and Benefits 
11.1. Potential Risks 
The risks for this study are minimal.  Risks inherent to use of the Sophono system or surgical procedure 
are outlined in the potential AEs found in Section 12. 
11.2. Potential Benefits 
There may not be any direct medical benefits to the study subjects. This study will help the Sponsor 
evaluate the safety and effectiveness of the hearing system to develop future products to assist others 
with similar hearing impairment. Subjects will be reimbursed for their participation. 
11.3. Risk-Benefit Rationale 
As the risks to this study are minimal (limited to subject inconvenience), the benefits of the increased 
data portfolio on the safety and processor effectiveness outweigh the associated risks.  
 
 

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12. Adverse Event Assessments 
12.1. Definitions/Classifications 
The below definitions are standard ISO regulation definitions required for all Medtronic studies. These 
definitions are given with the understanding that the Sophono device is an approved device and not 
considered investigational.   
Adverse Event 
(ISO 14155:2011, 3.2) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device. 
 
Note: This definition includes events related to the investigational 
medical device or the comparator. 
 
Note: This definition includes events related to the procedures involved. 
Note: for users or other persons, this definition is restricted to events 
related to investigational medical devices. 
Adverse Device Effect 
(ADE) 
(ISO 14155:2011, 3.1) 
Adverse event related to the use of an investigational medical device. 
 
Note: This definition includes adverse events resulting from insufficient 
or inadequate instructions for use, deployment, implantation, 
installation, or operation or any malfunction of the investigational 
medical device. 
 
Note: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device. 
Serious Adverse Event 
(SAE) 
(ISO 14155:2011, 3.37) 
Adverse event that: 
a) Led to a death, 
b) Led to a serious deterioration in the health of the subject, that either 
resulted in: 
1) Resulted in a life threatening illness or injury, or 

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2) Resulted in a permanent impairment of a body structure or a body 
function, or 
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, 
or Led to fetal distress, fetal death or a congenital abnormality or birth 
defect. 
 
Note: 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. 
Serious Adverse Device 
Effect (SADE) 
(ISO 14155:2011, 3.36) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
 
Information regarding any reportable AEs and outlined in Tables 4 & 5 below, in relation to the device or 
the procedure (as determined by the Investigator) that occur during the study will be recorded.  This 
information will include, at a minimum, the date of the event, the seriousness of the event (prospective), 
the severity, actions taken, the outcome, and the relationship (if any) of the event to the device.  Subject 
continuation in the study as prescribed in this protocol following an AE is anticipated, unless determined 
otherwise by the Investigator. 
12.1.1. 
Classification of adverse events 
SEVERITY OF EVENT 
All AEs will be assessed by the clinician using the following guidelines to describe severity. 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy 
or other treatment. Severe events are usually potentially life-threatening or incapacitating. 

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RELATIONSHIP OF DEVICE 
The clinician’s assessment of an AE's relationship to study device is part of the documentation process, 
but it is not a factor in determining what is or is not reported in the study. If there is any doubt as to 
whether a clinical observation is an AE, the event should be reported. All AEs must have their relationship 
to study device assessed. In a clinical trial, the study product must always be suspect. To help assess, 
the following guidelines are used. 
Not related:  relationship to the device or procedures can be excluded when: 
• 
the event is not a known side effect of the product category the device belongs to or of similar 
devices and procedures; 
• 
the event has no temporal relationship with the use of the investigational device or the 
procedures; 
• 
the serious event does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible; 
• 
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or increase of the 
level of activation/exposure), do not impact on the serious event; 
• 
the event involves a body-site or an organ not expected to be affected by the device or 
procedure; 
• 
the serious event can be attributed to another cause (e.g. an underlying or concurrent illness/ 
clinical condition, an effect of another device, drug, treatment or other risk factors); 
• 
the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable; 
• 
harms to the subject are not clearly due to use error; 
• 
In order to establish the non-relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/procedures and the serious event. 
Unlikely:  the relationship with the use of the device seems not relevant and/or the event can be 
reasonably explained by another cause, but additional information may be obtained. 
Possible:  the relationship with the use of the investigational device is weak but cannot be ruled out 
completely. Alternative causes are also possible (e.g. an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or treatment). Cases were relatedness cannot be 
assessed or no information has been obtained should also be classified as possible. 

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Probable:  the relationship with the use of the investigational device seems relevant and/or the event 
cannot reasonably explained by another cause, but additional information may be obtained. 
Causal relationship:  the serious event is associated with the investigational device or with procedures 
beyond reasonable doubt when: 
• 
the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures; 
• 
the event has a temporal relationship with investigational device use/application or procedures; 
• 
the event involves a body-site or organ that 
• 
the investigational device or procedures are applied to; 
• 
the investigational device or procedures have an effect on; 
• 
the serious event follows a known response pattern to the medical device (if the response 
pattern is previously known); 
• 
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
• 
other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment) have been adequately ruled out; 
• 
harm to the subject is due to error in use; 
• 
the event depends on a false result given by the investigational device used for diagnosis, when 
applicable; 
• 
In order to establish the relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the serious event. 
Where the relationship remains uncertain, it should not exclude the relatedness and the event should be 
classified as “possible”. 
EXPECTEDNESS 
An anticipated adverse event is defined as an AE, the nature, severity, or degree of incidence of which is 
known and identified in applicable product labeling, published literature or the Investigational Plan or 
Informed Consent.   
Based on event reports through literature review (15-19) anticipated Surgical Related AE’s possibly noted 
in the Operative Report during the retrospective medical chart review should be reported on the 
appropriate CRF.  These events may include: 
 

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Table 4. Surgical Related Adverse Events 
Event 
Excessive Bleeding 
Rupture of Dura 
Cerebrospinal Fluid (CSF) Leak 
Anesthesia Related Complications 
 
Anticipated Post-operative Related AE’s possibly seen in the retrospective medical chart review or at the 
office visit and their reportability within the study may include: 
 
Table 5. Post-Operative Related Adverse Events 
Event 
Reportable Criteria 
Abscess 
Requiring medical intervention 
Bleeding 
Requiring medical intervention 
Dehiscence (at Incision Site)  
Requiring medical intervention 
Depilation (Loss of Hair at Implant Site) 
Excessive or cosmetically bothersome 
Hematoma 
Requiring medical intervention 
Hyperemia 
Excessive or requiring medical intervention 
Infection (i.e. Cellulitis, Bacterial, etc.) 
Requiring medical intervention 
Inflammation/Skin Irritation (Redness) 
Holger 2, 3, 4 
Numbness (Hypoesthesia) 
Notable or bothersome to subject 

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Pain (Local) 
Prolonged surgical procedure pain or pain lasting more than 
10 days 
Pressure (at the Implant Site) 
Feeling of pressure continuing after subject begins using the 
processor 
Scarring 
Abnormal or Hypertrophic 
Skin Necrosis (Pressure) 
Requiring medical intervention 
Swelling 
Continuing after subject begins using the processor 
12.2. Reporting of Adverse Events 
Clinical information on AEs (as defined above), their presentation, date of event, management, 
relationship and outcome must be reported on a CRF and sent to Medtronic.  Subjects with ongoing AEs 
at the time of the prospective visit may not exit the study until the AE has been resolved or is determined 
not able to be resolved.  As this is a post-market study of a marketed device the sponsor and investigator 
will comply with regulations on event reporting according to the Medical Device Reporting System (MDR). 
The designated study personnel will have two opportunities to collect AE’s for each subject: 
At the retrospective data collection of Sophono implantation and post-implantation, any surgical 
procedure or device related AE will be recorded on the applicable CRF. This data collection may occur at 
any time after the subject consents to the study. No safety reporting to IRBs will be required for 
retrospective events. 
At the follow-up visit, the designated study personnel will examine and query the subject on the 
experience of any AEs, and designated study personnel will record data on the applicable CRF.  This data 
collection may occur at any time after the subject consents to the study. These prospective observed 
events will be reported to IRBs or other committees according to the rules and timeframe of the 
governing site or IRB. 
No AEs will be collected after the subject exits the study. 
 
 

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13. Statistical Design and Methods 
13.1. Sample size 
Since the primary endpoint is composed of a safety and efficacy endpoint, the sample was determined by 
the primary objective on safety because it requires the larger sample size. An approximate total of 100 
subjects will be enrolled. 
Sample size on safety 
The sample size calculation was estimated using data from previous studies with a precision-based 
calculation. (20, 21)  Recent data have shown that 15.2% of percutaneous implants are lost in children 
and adverse skin reactions were found in 7.8 % during follow-up visits. (21) Using this information and 
assuming a lower incidence of implant loss in transcutaneous devices (19, 22, 23) and a lower incidence 
of skin reaction (18, 24), a minimum incidence of 14% of any adverse events with a sample size of 72 
subjects will be able to obtain a 95% confidence level with a precision of +/- 9% (ranging from 5% to 
23%).  Considering a 25% withdrawal or potential dropout rate, a total of approximately 100 subjects will 
be enrolled. 
Sample size on efficacy 
It is expected that at least 6 paired subjects with the pure tone audiometry evaluation will be needed in 
order to demonstrate a difference in means between unaided and aided measurements in Hearing 
Improvement measured as PTA. From a literature search we found that studies have shown an average 
of 50% improvement on hearing measured as PTA.(13, 20, 21, 25-34) In the paper of Siegert (34) the 
mean and standard deviation of pure tone audiometry in 21 patients was 58.7±8.2 dB HL unaided and 
29.7± 8.2 dB HL aided. Based on these values, alpha level 5%, power 95% and two-sided test, a total of 
6 paired subjects are needed.  
13.2. Data analysis and reporting 
A detailed description of the statistical methods will be contained in the Statistical Analysis Plan. Any 
change to the data analysis methods described in this section and/or the Statistical Analysis Plan will 
require an amendment only if it changes a principal feature of the study description. Any other changes 
to the data analysis methods will be described and justified in the Final Report or publication. 
It is anticipated that SAS (SAS Institute Inc., Cary, NC, USA) will be used to perform all statistical 
analyses. Statistical tests will be based on a two-sided significance level of 0.05. No adjustments for 

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multiple comparisons will be performed. Since the impact of missing data is expected to be small no 
multiple imputation method for missing data is planned. However, should the issue of missing data arise, 
the choice of the imputation method for missing data will depend on the pattern of missing data and the 
type of the imputed variable.   
The study is a multicenter trial and a multicenter impact on primary outcome will be investigated. A 
description on primary outcome by sites will be provided. 
Outliers and influential observations will be identified via graphical plots. Once outliers or influential 
observations are identified, the study team will be informed and according to their decision the analysis 
for primary endpoint may be repeated excluding the outliers. Additional exploratory analyses will be 
conducted as deemed appropriate. 
Descriptive statistics will be used to summarize patient characteristics. For categorical variables, the 
minimum description will consist of the sample size, numbers of missing data and valid data, the 
frequency and the percentage of each category. Denominators for calculation of percentages will be 
taken as the number of subjects with available (not missing or unknown) observations in the specified 
patients sets and groups unless otherwise stated. Percentages will be presented with no decimal.  For 
continuous variables, the description will consist at least of the sample size (N), number of subjects with 
non-missing observation (n), mean, standard deviation, standard error, minimum, median and maximum. 
For n<3, only mean, minimum and maximum will be displayed. In general, minimums and maximums will 
be presented to the same level of accuracy as the raw data; means and medians will be presented to 1 
further decimal place; if appropriate, standard deviation and standard error will be presented to 2 further 
decimal places. 
The primary analysis is based on safety and effectiveness. 
13.3. Safety endpoint  
Event rates, weighted for center, will be displayed together with their 95% confidence interval (95%CI); 
for each possible sub-group, analyses will be compared by means of a mixed Poisson model, with center 
included as random effect. In the presence of over dispersion, negative binomial regression will be used. 
Over dispersion will be assessed both with a goodness-of-fit test and a likelihood ratio test for alpha=0. 
The incidence rate ratio (IRR) and 95%CI will be reported [IRR=rate group1 / rate group2]. The 
exposure time (days/months) will be computed from implantation to the date of the follow-up visit for 
each patient [(data end – data in)/30.4]. 

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Specific events will be analyzed using survival analysis. The analysis will be supported by a Kaplan Meier 
curve indicating the number of patients at risk and comparison of curves will be done using the 
generalized Log-Rank Test where appropriate. The exposure time (months) will be computed from the 
date of the implantation to the date of the last available follow-up or date of event: [(data end – data 
in)/30.4].  
13.4. Effectiveness endpoint  
The change between unaided and aided measurements will be analyzed by means of paired (samples) t-
test or Wilcoxon signed rank sum test according to the normal or non-normal distribution or McNemar 
test for categorical variables where appropriate. Categorical variable comparisons will be performed using 
a Chi-square test or a Cochran-Mantel-Haenszel test for trend for ordinal variables with 3 or more 
categories. The mean change will be displayed together with their 95% confidence interval (95%CI).  
Analysis of secondary endpoints based on comparisons between groups on continuous measurements will 
be performed by Student’s t-test or non-parametric test (Mann–Whitney U test) for normal and non-
normal distributions, respectively. Normality will be assessed by means of Shapiro-Wilks test and the p-
value will be reported. Analysis of secondary endpoints based on the change over time (if more than 3 
measurements) will be analyzed by means of GEE models or mixed models for continuous outcomes to 
account for repeated measures using patient as the subject. The dependent variable will be pre-log 
transformed depending on normal or non-normal distribution. The model will have the clinical outcomes 
as dependent variables and baseline values, visits and other covariates as explanatory variables. All 
assumptions for regression models will be assessed by viewing plots of the residual values. The plot for 
the mean change over time will be reported. 
14. Ethics 
14.1. Statement(s) of Compliance  
• 
The study shall be conducted in accordance with the protocol and ethical principles that have 
their origin in the Declaration of Helsinki. 
• 
The study will be conducted in compliance with this protocol, GCP, and 21 CFR 50, 21 CFR 54, 
and 21 CFR 56. 
• 
The clinical study will not begin at the site until IRB approval is received.   
 

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15. Study Administration 
15.1. Monitoring  
This study will be conducted and monitored according to the highest scientific and ethical standards, 
based on standard operating procedures of the Sponsor or designee, and ethics guidelines as required by 
regulation and law, and as appropriate to the prospective research populations. The following guidance’s 
and regulations have been consulted in preparing the study’s protocol and procedures:  
-Title 21 of the Code of Federal Regulations (21 CFR) Parts:  
• 
50 Protection of Human Subjects  
• 
54 Financial Disclosure by Clinical Investigators  
• 
56 Institutional Review Boards  
Employees of the Sponsor, or its designees, who have received appropriate training, will serve as the 
Study Monitor(s). Study monitoring activities will include review of completed study documents, source 
document verification and reporting, verification of database accuracy, and assessment of the 
completeness and accuracy of the data. A final monitoring report will be prepared to document that all 
protocol requirements were satisfied. The Study Monitor(s) will also assume responsibility for 
communications between the Study Investigators and the Sponsor. 
15.2. Data Management 
All data required for this study will be captured via eCRFs using Oracle Clinical’s Remote Data Capture 
(RDC) module. The associated software and database have been designed to meet regulatory compliance 
requirements for deployment as part of a validated system compliant with laws and regulations applicable 
to the conduct of clinical studies that use electronic records and signatures. System backups for data 
stored in the Oracle Clinical system will be consistent with Medtronic standard procedures.  
 
The Investigator will ensure that all eCRFs are completed promptly, completely, and accurately. Only 
authorized study personnel are permitted to enter data. These tasks may be delegated by the 
Investigator as desired and noted on a Delegation of Authority Log. The Sponsor will provide training and 
instructions to assist with eCRF completion. In the event of data discrepancies, the study center staff will 
be contacted and asked to resolve queries electronically in the RDC system. Any irresolvable data-related 

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issues will be routed to the Sponsor for review and final disposition. An audit trail is maintained in Oracle 
Clinical to capture any corrections or changes of the eCRFs.  
 
Medtronic will only consider eCRFs to be complete when all data discrepancies between source data and 
eCRFs have been resolved and eCRF content has been reviewed by a Sponsor-representative monitor. In 
addition, all eCRFs must also be reviewed and electronically signed by the Investigator, indicating his/her 
agreement with the accuracy of all recorded data. The Investigator will provide his/her electronic 
signature on the eCRFs.  
Prior to data extraction, all collected data will undergo a final verification by Data Management. 
Documentation of this verification will be maintained in the Sponsor study files. Upon the completion of 
the verification, data will be extracted and transferred to the appropriate personnel for analysis. 
15.3. Direct Access to Source Data/Documents  
The Sponsor, its affiliates, IRB, or government officials may audit the study site to evaluate the conduct 
of the study. The sponsor and its representatives expect to have access to the source data for this study 
including medical records. 
15.4. Confidentiality 
The Sponsor and its affiliates may access subject confidential information during the course of the study.  
Confidentiality of the data shall be observed by all parties at all times throughout the clinical study.  All 
data shall be secured against unauthorized access. 
15.5. CIP Amendments 
If during the course of the study the Sponsor assesses that an amendment is necessary the Sponsor will 
follow all applicable internal procedures to amend the protocol, and if applicable, the IC.  Any 
amendments to the protocol or IC will be reviewed and approved by the IRB. 
15.6. Record Retention 
All documentation generated as a result of this clinical study must be properly prepared and maintained. 
Records must be maintained by the investigational site for a minimum of two years after study 
completion. No study document shall be destroyed without prior written agreement between the Sponsor 

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and the investigational site. All documentation generated as a result of this clinical study must be 
properly prepared and maintained. Table 6, below, describes the records and reports to be maintained 
during and after the study. 
15.6.1. 
Sponsor Requirements 
All original hard copy or certified copies and electronic data will be retained by the Sponsor per standard 
operating policy on documentation retention. 
15.6.2. 
Investigational Site Requirements 
All site generated hard copy and electronic data will be retained by the site per specific institutional 
standard operating policy. Should the investigator wish to assign the study record to another party or 
move them to another location, the Sponsor must be notified in writing and agree to the change. 

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Table 6. Sponsor and Investigator Records and Reports 
Records 
Maintained by 
Sponsor 
Maintained by 
Investigator 
Device Accountability (shipment/receipt, assignment, 
destruction, return) 
x 
x 
Case Histories (CRFs, IC/PIS, AE) 
x 
x 
Protocols/Deviations (obsolete, change history record, 
rationale) 
x 
x 
Agreements (Confidential, Investigator, Consulting) 
x 
x 
Training Records (Sponsor, institution, topic) 
x 
x 
Report 
Prepared by 
Sponsor For 
Prepared by 
Investigator 
For 
Lack of IC/Authorization 
N/A 
Sponsor, IRB 
Unanticipated Serious Adverse Device Effects (USADE) 
Investigators, IRB 
Sponsor, IRB 
Protocol Deviations 
N/A 
Sponsor, IRB* 
Withdrawal of IRB Approval 
Investigators, IRB 
Sponsor, IRB 
Final Report 
Investigators, IRB 
(if required) 
IRB (if required) 
*In accordance with specific Ethics Committee requirements 
15.7. Publication and Use of Information 
The Sponsor must be notified of any intent to publish data stemming from this clinical study. Conditions 
of use of the data are governed by the terms of the Investigator Agreement and Publication Plan. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov.  
15.8. Suspension or Early Termination 
Should the study be terminated for cause, or prior to achieving the protocol objectives, the Sponsor 
reserves the right to resume or discontinue the study at its discretion.  If the study is terminated or 
suspended, the Sponsor will promptly inform the Investigators/Institutions of the reason(s) for 
termination or suspension. 

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16. References 
1.  
Mudry A, Tjellstrom A. Historical background of bone conduction hearing devices and bone 
conduction hearing aids. [Internet]. 71st ed. Vol. 71, Advances in oto-rhino-laryngology. 
Switzerland: PubMed; 2011. p. 1–9. Available from: 
https://libcontent.medtronic.com:2908/pubmed/21389699 
2.  
McDermott A-L, Williams J, Kuo M, Reid A, Proops D. The birmingham pediatric bone-anchored 
hearing aid program: a 15-year experience. [Internet]. 30th ed. Vol. 30, Otology & neurotology : 
official publication of the American Otological Society, American Neurotology Society [and] 
European Academy of Otology and Neurotology. United States: PubMed; 2009. p. 178–83. 
Available from: https://libcontent.medtronic.com:2908/pubmed/18957903 
3.  
Saliba I, Woods O, Caron C. BAHA results in children at one year follow-up: a prospective 
longitudinal study. [Internet]. 74th ed. Vol. 74, International journal of pediatric 
otorhinolaryngology. Ireland: Elsevier Science; 2010. p. 1058–62. Available from: 
https://libcontent.medtronic.com:2908/pubmed/20594601 
4.  
Marsella P, Scorpecci A, Vallarino MV, Di Fiore S, Pacifico C. Sophono in Pediatric Patients: The 
Experience of an Italian Tertiary Care Center. [Internet]. 151st ed. Vol. 151, Otolaryngology--
head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck 
Surgery. England: PubMed; 2014. p. 328–32. Available from: 
https://libcontent.medtronic.com:2908/pubmed/24714216 
5.  
Dun CAJ, Faber HT, de Wolf MJF, Mylanus EAM, Cremers CWRJ, Hol MKS. Assessment of more 
than 1,000 implanted percutaneous bone conduction devices: skin reactions and implant survival. 
[Internet]. 33rd ed. Vol. 33, Otology & neurotology : official publication of the American 
Otological Society, American Neurotology Society [and] European Academy of Otology and 
Neurotology. United States: PubMed; 2012. p. 192–8. Available from: 
https://libcontent.medtronic.com:2908/pubmed/22246385 
6.  
Lloyd S, Almeyda J, Sirimanna KS, Albert DM, Bailey CM. Updated surgical experience with bone-
anchored hearing aids in children. [Internet]. 121st ed. Vol. 121, The Journal of laryngology and 
otology. England: PubMed; 2007. p. 826–31. Available from: 
https://libcontent.medtronic.com:2908/pubmed/17210090 
7.  
De Wolf MJF, Hol MKS, Huygen PLM, Mylanus EAM, Cremers CWRJ. Nijmegen results with 
application of a bone-anchored hearing aid in children: simplified surgical technique. [Internet]. 

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117th ed. Vol. 117, The Annals of otology, rhinology, and laryngology. United States: PubMed; 
2008. p. 805–14. Available from: https://libcontent.medtronic.com:2908/pubmed/19102125 
8.  
Dun CAJ, Faber HT, de Wolf MJF, Mylanus EAM, Cremers CWRJ, Hol MKS. Assessment of more 
than 1,000 implanted percutaneous bone conduction devices: skin reactions and implant survival. 
[Internet]. 33rd ed. Vol. 33, Otology & neurotology : official publication of the American 
Otological Society, American Neurotology Society [and] European Academy of Otology and 
Neurotology. United States: PubMed; 2012. p. 192–8. Available from: 
https://libcontent.medtronic.com:2908/pubmed/22246385 
9.  
Hough J, Vernon J, Johnson B, Dormer K, Himelick T. Experiences with implantable hearing 
devices and a presentation of a new device. [Internet]. 95th ed. Vol. 95, The Annals of otology, 
rhinology, and laryngology. United States: PubMed; 1986. p. 60–5. Available from: 
https://libcontent.medtronic.com:2908/pubmed/3947005 
10.  
Hakansson B, Tjellstrom A, Carlsson P. Percutaneous vs. transcutaneous transducers for hearing 
by direct bone conduction. [Internet]. 102nd ed. Vol. 102, Otolaryngology--head and neck 
surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery. 
England: PubMed; 1990. p. 339–44. Available from: 
https://libcontent.medtronic.com:2908/pubmed/2113260 
11.  
Gatehouse S, Browning GG. The output characteristics of an implanted bone conduction 
prosthesis. [Internet]. 15th ed. Vol. 15, Clinical otolaryngology and allied sciences. England: 
Wiley; 1990. p. 503–13. Available from: https://libcontent.medtronic.com:2908/pubmed/2073757 
12.  
Snik AF, Dreschler WA, Tange RA, Cremers CW. Short- and long-term results with implantable 
transcutaneous and percutaneous bone-conduction devices. [Internet]. 124th ed. Vol. 124, 
Archives of otolaryngology--head & neck surgery. United States: PubMed; 1998. p. 265–8. 
Available from: https://libcontent.medtronic.com:2908/pubmed/9525509 
13.  
Siegert R. Partially implantable bone conduction hearing aids without a percutaneous abutment 
(Otomag): technique and preliminary clinical results. [Internet]. 71st ed. Vol. 71, Advances in 
oto-rhino-laryngology. Switzerland: PubMed; 2011. p. 41–6. Available from: 
https://libcontent.medtronic.com:2908/pubmed/21389703 
14.  
Siegert R. [Magnetic coupling of partially implantable bone conduction hearing aids without open 
implants]. [Internet]. 89th ed. Laryngo- rhino- otologie. Germany: PubMed; 2010. p. 346–51. 
(Die magnetische Ankopplung von Knochenleitungshorgeraten ohne offene Implantate - Prinzip 

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und erste Ergebnisse einer neuen Knochenleitungsversorgung.; vol. 89). Available from: 
https://libcontent.medtronic.com:2908/pubmed/20232281 
15.  
Wazen JJ, Young DL, Farrugia MC, Chandrasekhar SS, Ghossaini SN, Borik J, et al. Successes and 
complications of the Baha system. [Internet]. 29th ed. Vol. 29, Otology & neurotology : official 
publication of the American Otological Society, American Neurotology Society [and] European 
Academy of Otology and Neurotology. United States: PubMed; 2008. p. 1115–9. Available from: 
https://libcontent.medtronic.com:2908/pubmed/18833013 
16.  
Badran K, Arya AK, Bunstone D, Mackinnon N. Long-term complications of bone-anchored 
hearing aids: a 14-year experience. [Internet]. 123rd ed. Vol. 123, The Journal of laryngology 
and otology. England: PubMed; 2009. p. 170–6. Available from: 
https://libcontent.medtronic.com:2908/pubmed/18492306 
17.  
Kraai T, Brown C, Neeff M, Fisher K. Complications of bone-anchored hearing aids in pediatric 
patients. [Internet]. 75th ed. Vol. 75, International journal of pediatric otorhinolaryngology. 
Ireland: Elsevier Science; 2011. p. 749–53. Available from: 
https://libcontent.medtronic.com:2908/pubmed/21470698 
18.  
Marfatia H, Priya R, Sathe NU, Mishra S. Challenges During Baha Surgery: Our Experience. 
[Internet]. 68th ed. Vol. 68, Indian journal of otolaryngology and head and neck surgery : official 
publication of the Association of Otolaryngologists of India. India: PubMed; 2016. p. 317–21. 
Available from: https://libcontent.medtronic.com:2908/pubmed/27508133 
19.  
Badran K, Arya AK, Bunstone D, Mackinnon N. Long-term complications of bone-anchored 
hearing aids: a 14-year experience. [Internet]. 123rd ed. Vol. 123, The Journal of laryngology 
and otology. England: PubMed; 2009. p. 170–6. Available from: 
https://libcontent.medtronic.com:2908/pubmed/18492306 
20.  
Hol MKS, Nelissen RC, Agterberg MJH, Cremers CWRJ, Snik AFM. Comparison between a new 
implantable transcutaneous bone conductor and percutaneous bone-conduction hearing implant. 
[Internet]. 34th ed. Vol. 34, Otology & neurotology : official publication of the American 
Otological Society, American Neurotology Society [and] European Academy of Otology and 
Neurotology. United States: PubMed; 2013. p. 1071–5. Available from: 
https://libcontent.medtronic.com:2908/pubmed/23598702 
21.  
Nelissen RC, Agterberg MJH, Hol MKS, Snik AFM. Three-year experience with the Sophono in 
children with congenital conductive unilateral hearing loss: tolerability, audiometry, and sound 
localization compared to a bone-anchored hearing aid. [Internet]. 273rd ed. Vol. 273, European 

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archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-
Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - 
Head and Neck Surgery. Germany: Generic; 2016. p. 3149–56. Available from: 
https://libcontent.medtronic.com:2908/pubmed/26924741 
22.  
De Wolf MJF, Hol MKS, Huygen PLM, Mylanus EAM, Cremers CWRJ. Nijmegen results with 
application of a bone-anchored hearing aid in children: simplified surgical technique. [Internet]. 
117th ed. Vol. 117, The Annals of otology, rhinology, and laryngology. United States: PubMed; 
2008. p. 805–14. Available from: https://libcontent.medtronic.com:2908/pubmed/19102125 
23.  
Wazen JJ, Young DL, Farrugia MC, Chandrasekhar SS, Ghossaini SN, Borik J, et al. Successes and 
complications of the Baha system. [Internet]. 29th ed. Vol. 29, Otology & neurotology : official 
publication of the American Otological Society, American Neurotology Society [and] European 
Academy of Otology and Neurotology. United States: PubMed; 2008. p. 1115–9. Available from: 
https://libcontent.medtronic.com:2908/pubmed/18833013 
24.  
Kraai T, Brown C, Neeff M, Fisher K. Complications of bone-anchored hearing aids in pediatric 
patients. [Internet]. 75th ed. Vol. 75, International journal of pediatric otorhinolaryngology. 
Ireland: Elsevier Science; 2011. p. 749–53. Available from: 
https://libcontent.medtronic.com:2908/pubmed/21470698 
25.  
Marsella P, Scorpecci A, Vallarino MV, Di Fiore S, Pacifico C. Sophono in Pediatric Patients: The 
Experience of an Italian Tertiary Care Center. [Internet]. 151st ed. Vol. 151, Otolaryngology--
head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck 
Surgery. England: PubMed; 2014. p. 328–32. Available from: 
https://libcontent.medtronic.com:2908/pubmed/24714216 
26.  
Centric A, Chennupati SK. Abutment-free bone-anchored hearing devices in children: initial 
results and experience. [Internet]. 78th ed. Vol. 78, International journal of pediatric 
otorhinolaryngology. Ireland: Elsevier Science; 2014. p. 875–8. Available from: 
https://libcontent.medtronic.com:2908/pubmed/24612554 
27.  
Magliulo G, Turchetta R, Iannella G, di Valperga Masino R, de Vincentiis M. Sophono Alpha 
System and subtotal petrosectomy with external auditory canal blind sac closure. [Internet]. 
272nd ed. Vol. 272, European archives of oto-rhino-laryngology : official journal of the European 
Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for 
Oto-Rhino-Laryngology - Head and Neck Surgery. Germany: Generic; 2015. p. 2183–90. Available 
from: https://libcontent.medtronic.com:2908/pubmed/24908070 

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28.  
Escorihuela-Garcia V, Llopez-Carratala I, Pitarch-Ribas I, Latorre-Monteagudo E, Marco-Algarra J. 
Initial experience with the Sophono Alpha 1 osseointegrated implant. [Internet]. 65th ed. Vol. 65, 
Acta otorrinolaringologica espanola. Spain: Ediciones Doyma, S.L.; 2014. p. 361–4. Available 
from: https://libcontent.medtronic.com:2908/pubmed/24725584 
29.  
Centric A, Chennupati SK. Abutment-free bone-anchored hearing devices in children: initial 
results and experience. [Internet]. 78th ed. Vol. 78, International journal of pediatric 
otorhinolaryngology. Ireland: Elsevier Science; 2014. p. 875–8. Available from: 
https://libcontent.medtronic.com:2908/pubmed/24612554 
30.  
Baker S, Centric A, Chennupati SK. Innovation in abutment-free bone-anchored hearing devices 
in children: Updated results and experience. [Internet]. 79th ed. Vol. 79, International journal of 
pediatric otorhinolaryngology. Ireland: Elsevier Science; 2015. p. 1667–72. Available from: 
https://libcontent.medtronic.com:2908/pubmed/26279245 
31.  
Zernotti ME, Di Gregorio MF, Galeazzi P, Tabernero P. Comparative outcomes of active and 
passive hearing devices by transcutaneous bone conduction. [Internet]. 136th ed. Vol. 136, Acta 
oto-laryngologica. England: PubMed; 2016. p. 556–8. Available from: 
https://libcontent.medtronic.com:2908/pubmed/26981711 
32.  
Denoyelle F, Coudert C, Thierry B, Parodi M, Mazzaschi O, Vicaut E, et al. Hearing rehabilitation 
with the closed skin bone-anchored implant Sophono Alpha1: results of a prospective study in 15 
children with ear atresia. [Internet]. 79th ed. Vol. 79, International journal of pediatric 
otorhinolaryngology. Ireland: Elsevier Science; 2015. p. 382–7. Available from: 
https://libcontent.medtronic.com:2908/pubmed/25617189 
33.  
O’Niel MB, Runge CL, Friedland DR, Kerschner JE. Patient Outcomes in Magnet-Based 
Implantable Auditory Assist Devices. [Internet]. 140th ed. Vol. 140, JAMA otolaryngology-- head 
& neck surgery. United States: PubMed; 2014. p. 513–20. Available from: 
https://libcontent.medtronic.com:2908/pubmed/24763485 
34.  
Siegert R, Kanderske J. A new semi-implantable transcutaneous bone conduction device: clinical, 
surgical, and audiologic outcomes in patients with congenital ear canal atresia. [Internet]. 34th 
ed. Vol. 34, Otology & neurotology : official publication of the American Otological Society, 
American Neurotology Society [and] European Academy of Otology and Neurotology. United 
States: PubMed; 2013. p. 927–34. Available from: 
https://libcontent.medtronic.com:2908/pubmed/23770689 
 
  

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17. Appendices  
Appendix A: APHAB Version A 
Appendix B: Satisfaction Questionnaire 
 
 

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Appendix A 
 
 

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Appendix B 
 
 

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Satisfaction Questionnaire 
 
Name: ______________________________ 
 
 
Date :_______________ 
 
Please answer the following questions regarding your current use of the Sophono and quality of life.  
Please choose only one option for each question: 
 
Overall, how satisfied are you with your Sophono processor? 
□ 
Very Satisfied 
□ 
Satisfied 
□ 
Neutral (Neither Satisfied or Dissatisfied) 
□ 
Dissatisfied 
□ 
Very Dissatisfied 
 
Would you recommend the Sophono system to another patient with a conductive hearing problem? 
□ 
Yes 
□ 
No 
□ 
Not Sure 
 
How satisfied or dissatisfied are you with the appearance of the hearing device? 
□ 
Very Satisfied 
□ 
Satisfied 
□ 
Neutral (Neither Satisfied or Dissatisfied) 
□ 
Dissatisfied 
□ 
Very Dissatisfied 
 
 
 
 

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How easy or difficult is it to operate the hearing device as instructed? 
□ 
Very Easy 
□ 
Easy 
□ 
Neutral (Neither Easy or Difficult) 
□ 
Difficult 
□ 
Very Difficult 
 
Listed below are some Sophono features.  For each feature, please indicate how satisfied you are with 
that feature.  Please choose only one option for each question. 
Overall comfort of device 
□ 
Always 
□ 
Sometimes 
□ 
Never 
Visibility to others 
□ 
Always 
□ 
Sometimes 
□ 
Never 
Clearness of tone and sounds 
□ 
Always 
□ 
Sometimes 
□ 
Never 
Durability 
□ 
Always 
□ 
Sometimes 
□ 
Never 
Reliability 
□ 
Always 
□ 
Sometimes 
□ 
Never 

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Magnet-spacer strength in day to day activities 
□ 
Always 
□ 
Sometimes 
□ 
Never 
Magnet-spacer strength in physical activities 
□ 
Always 
□ 
Sometimes 
□ 
Never 
Do you use a different strength for physical activities? 
□ 
Yes 
□ 
No 
Ability to tell locations of sounds 
□ 
Always 
□ 
Sometimes 
□ 
Never