Real World Perspectives on Advancements in Hearing Aid Technology
Phase: NA
Conditions: Hearing Loss
Sponsor: Sonova AG

 
Study Protocol and Statistical Analysis Plan 
 
 
 
 
 
Real-world perspectives on advancements 
in hearing aid technology 
 
 
 
 
 
Version 3 
 
10/24/2022 
 
 
 
 
 
NCT05468918 

 
 
 
 
Protocol Title 
 
Real-world perspectives on advancements in hearing aid technology 
 
1 
Background    
Understanding speech in a noisy environment can be difficult for people with hearing loss 
even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e., 
directional microphones, noise reduction, noise cancelers) to try to improve SNR to increase 
the speech understanding in these difficult listening situations. 
 
One of Phonak’s early directional microphone systems used a dual microphone directional 
microphone in the programmable behind-the-ear (BTE) PiCS Audio-Zoom and improved the 
SNR by about 8 dB relative to the omnidirectional microphone in a lab setting (Valente et al, 
1995). 
Stewart et. al, 2019 described various Phonak microphone systems. Real Ear Sound (RES) is a 
microphone mode in Phonak hearing aids that mimics the directional benefit that is provided 
naturally by the shape and resonances of the pinna. UltraZoom (UZ) was introduced with 
Phonak’s Spice platform and is a monaural adaptive beamformer. StereoZoom was first 
introduced in Quest hearing aids as a static binaural beamformer creating a narrow focus. With 
Venture hearing aids, StereoZoom became an adaptive binaural beamformer that is active in 
the SPiLN program. 
StereoZoom has shown a 1.5 dB improvement over the monaural beamformer, UZ, in noise 
when speech is in the front in various studies summarized by Stewart et. al, 2019. 
StereoZoom is beneficial when the dominant speech is located to the front in a noisy 
environment, however if the dominant speech is located to the sides or back, a narrow 
beamformer to the front is not ideal. Speech Locator is a feature that is new with Phonak Lumity 
that determines with the dominant talker is located in the front, back, left or right and steers 
the beamformer to a different/wider directional setting. StereoZoom 2.0 will also be introduced 
with Lumity and it allows for activation at a lower noise floor compared to the earlier 
version. The activation of StereoZoom 2.0 at a lower noise floor level is beneficial because 
research has indicated that the typical "speech in noise" environment is around 68 dB and 
typically not with a negative SNR (Smeds et. al, 2015 and Wu et. al, 2018). In addition, the 
transition into the SPiLN program for Audéo Lumity is smooth and only one ear needs to 
meet the criteria to switch into this program from AutoSense OS 5.0. 
Audéo Lumity with APD 2.0, AutoSense OS 5.0, Speech Locator and StereoZoom 2.0 is 
expected to require less listening effort in noisy environments compared to previous generations 
with APD, AutoSense OS 3.0 and StereoZoom but has not been directly compared. In the lab 
setting, this investigation will focus on making it similar to the "real-world" by using a common 
level of a speech in noise situation with common SNRs when obtaining data on listening 
effort for Audéo Lumity vs. a previous generation device. During the home trial, inferences will 
be made from real-world situations recorded with EMA data regarding microphone mode 
settings for Lumity and a compartor device. 
 
 
 

2 
Objectives 
Primary Objective: 
Evaluate whether Audéo Lumity provides lower perceived listening effort (at least ~1 
point on a 10 point rating scale) with speech from the side and from the back in noisy situations 
compared to a previous generation device with adults who have moderate to moderately severe 
hearing loss during a lab session using realistic overall noise levels and SNRs. 
 
3 
Description of the investigational device 
The Audeo Lumity is the latest generation of Audeo RIC hearing aids. There are three form 
factors: R (Rechargeable), RT (Rechargeable with Telecoil) and RL (Rechargeable lifeproof). 
This study will use the Audeo Lumity 90-R. 
The overall intended purpose of the device is to amplify and transmit sound ot the ear and 
thereby compensate for impaired hearing. 
 
4 
Design of the clinical investigation 
This clinical investigation is an interventional study executed at one investigation site with a 
confirmatory design. The investigation model is single group with a crossover design and is 
single blinded. In lab, listening effort will be evaluated with speech from the side and from the 
back in noisy situations with both HIs. 
 
5 
Risks and benefits of the investigational device and clinical investigation 
Audéo L hearing instruments carry only minimal risks under normal use conditions and are 
intended to give the user auditory access to speech communication. There are no risks 
associated with the investigation procedures that are not associated with the use of the device. 
Participants in this investigation will benefit from the ability to hear and communicate in their 
daily lives, while experiencing only minimal risk associated with the use of the device.  
 
6 
Endpoints 
Primary endpoint: 
A subjective listening effort questionnaire with a 10-point scale will be used. This questionnaire 
includes some questions from the Speech, Spatial and Qualities of hearing Scale 
(SSQ; Gatehouse & Noble, 2004) and was used in a previous study at PARC. 
 
7 
Inclusion and Exclusion Criteria 
Subjects fulfilling all of the following inclusion criteria are eligible for the investigation: 
-N3-N4 sensorineural hearing loss 
-18+ years old 
-Experienced hearing aid user 
-Has a significant other/communication partner that could fill out a questionnaire about hearing 
aid performance during the home trial 
 
The presence of any of the following exclusion criteria will lead to the exclusion of the subject 
-Cognitive impairment 
-Unwilling to wear the hearing aid 
 
8 
Measurements and procedures 
The following measurements and procedures may be used during this investigation: Audiogram, 
speech intelligibility in noise (AZBio Sentences), RHHI_S, ASHA QCL, Listening effort 
questionnaire, Significant Other questionnaire, subjective questionnaire for ease of use. 

Data will be captured at the time of testing. Data will be stored electronically on a Sonova-
owned server and will be analyzed after all participants have completed all investigation tasks 
and appointments. Any paper-based data will be stored in a locked filing cabinet in which only 
authorized study personnel have access. 
 
9 
Statistical design and analysis 
Sample size was estimated using G*Power software for the planned analysis using RMANOVA 
with within-subjects factor of device. An effect size in partial eta squared was calculated 
using data from a previous conducted at the site utilizing the same subjective measure 
of listening effort. The prior study investigated devices from multiple HI manufacturers under 
similar conditions planned for the current investigation. The effect size calculated from the 
existing data was then assessed for clinical applicability. The resulting effect size equated to 
roughly a 1 point difference on the measurement scale, which was judged to be clinically 
relevant. 
This analysis will be conducted on a per protocol population (since the study involves a single 
group). Subjective listening effort ratings made during a laboratory session with two hearing 
instruments will be analyzed. 
Data supporting the primary objective will be subjected to RM-ANOVA with a within-subjects 
factor of device. Analysis will be conducted with JASP open source statistical software. JASP 
will also be used to calculate descriptive statistics and generate visualizations of the data 
supporting the primary objective. 
Adverse events, serious adverse events, and device deficiencies will be reported in a timely 
manner throughout the investigation. Appropriate action will be taken at the time of the report 
as outlined in this clinical investigation plan. 
 
10 
Investigation Duration 
The expected duration for each participant is approximately 2-3 weeks. The total expected 
duration of the study is 4-6 weeks. 
 
11 
Data handling and management 
This investigation will utilize paper-based and electronic CRFs. For all CRFs, the participants 
will be identified only by an anonymous code, which will not include their real names, initials, 
birthdates or identifying information. The code list will be stored separately on a restricted 
accesses server maintained by Sonova USA. All investigators and study staff will have address 
to the CRFs during the course of the investigation. Following the completion of this 
investigation, CRFs will be locked and maintained in the TMF and filing cabinet. 
Any paper-based data will be stored in a locked filing cabinet at the investigation site for 10 
years. All electronic data will be stored on an access-restricted server owned, operated, and 
maintained by Sonova USA for 10 years. Servers used to store data in this investigation are 
physically located in the US. 
Only authorized study personnel will have access. Permission to access data will be limited 
to study manager, monitor, PI, and essential research staff, as designated by the PI. 
All participants will be assigned an alphanumeric code by the study manager. There is no 
disclosure of personal information to anyone else but the investigation team and only members 
of the investigation team have access to these documents. Any identifiable information, 
such as the Subject ID Log, will be kept in a secure location at the investigative site. 
Source data is encoded and will be archived encoded as well. Participants and their respective 
data will be tracked on source data and source documents via their participant ID. The 
de-identified data will be kept for 10 years after the publication of the results. 
12 
Amendments to the CIP 

If it is necessary to make an amendment to this CIP, the changes to the CIP will be clearly 
identified with the date the change was made, and the version number will be incremented. 
Non-substantial amendments (e.g., correcting a typographical error) will be recorded as a minor 
version incrementation, whereas substantial amendments (e.g., a change to the study 
procedure or statistical plan) will be recorded as a major version incrementation. In an 
emergency situation, this CIP will be amended and updated only after participant health and 
safety have been assured and FDA/WIRB have been notified (as applicable). The amended CIP 
will go through the approval process and necessary signatures obtained from the study 
manager/sponsor, PI, and statistician. The amended CIP will be uploaded to the eQMS system 
as an additional revision. 
Any necessary amendments to the CIP will be communicated by the PI, study manager and/or 
sponsor. Necessary members of the investigation team will be trained on the amendments. 
 
13 
Deviations from clinical investigation plan 
Deviations from the CIP to protect the rights, safety and well-being of human participants under 
emergency circumstances may proceed without prior approval of the sponsor and the EC – 
such deviations will be documented and reported to the sponsor representative (Study 
Manager) and the EC as soon as possible. Apart from that the investigator is not allowed to 
deviate from this CIP unless that deviation does not influence the investigation data.  
 
14 
Device accountability 
Each investigational device will have its own unique serial number. The PI or authorized 
designee will keep records on the Device Accountability Log (TPL-157) in chapter 7 of the 
TMF_ISF for SRF-285. Details include: 
 Device Identifier 
 Serial Number 
 Date received from Sponsor 
 Date(s) of use 
 Participant ID 
 If a Device Deficiency was experienced 
 Date returned to Sponsor 
This log will be actively maintained throughout the trial and will be stored in the TMF following 
the completion of the investigation. 
 
15 
Informed consent process 
Prior to the beginning of the investigation, all participants will be provided with a written copy 
of an IRB-approved consent statement. The investigator will explain the consent document to 
the participant and answer any questions. Participants will be told explicitly that agreement to 
the consent document and their participation in the investigation is entirely voluntary and may 
be revoked at any time for any reason or no reason. 
Participants will be incentivized with a monetary stipend of 30 USD per hour spent at the 
investigation site, plus mileage reimbursement for round-trip travel between the investigation 
site and their home address. Mileage reimbursement will be calculated based on the shortest 
driving distance in miles multiplied by the Internal Revenue Service’s (IRS) standard mileage 
rate at the time the study concludes. 
 

Informed Consent will only be obtained by investigation participants who can provide informed 
consent themselves before enrollment. 
 
16 
Adverse events, adverse device effects and device deficiencies 
Device deficiencies and all adverse events (AE) including all serious adverse events (SAE) 
are collected, fully investigated and documented in the source document and appropriate case 
report form (CRF) during the entire investigation period, i.e. from participant’s informed con-sent 
until the last protocol-specific procedure, including a safety follow-up period (ISO-14155, 2020). 
Documentation includes dates of event, treatment, resolution, assessment of serious-ness and 
causal relationship to device and/or investigation procedure.  
Information on AEs is systematically collected during the regular investigation visits, and phone 
calls (if applicable).  
The investigator(s) will follow-up on a biweekly basis with any participant experiencing an AE 
until either a) the participant reports resolution of the AE or b) 8 weeks have passed since the 
participant’s final visit. If, however, the participant’s condition worsens throughout the 8 week 
follow-up period, the investigator will continue to follow-up biweekly until the AE is resolved or 
the participant’s condition stabilizes over an 8 week period.  
The reporting of Serious Adverse Events and Device Deficiencies follows the Regulation (EU) 
2017/745 and the MDCG 2020-10/1 Safety Reporting in Clinical Investigations of Medical 
Devices under Regulation (EU) 2017/745. 
The causality assessment of the SAE will be conducted according to MDCG 2020-10/1 Safety 
Reporting in Clinical Investigations of Medical Devices under Regulation (EU) 2017/745. 
 
17 
Vulnerable populations 
This investigation will not include any vulnerable populations. 
 
18  
Suspension or premature termination of the clinical investigation 
The study will be terminated if the majority of the participants are not able to wear the devices 
for the study visit.  
The study will be terminated if the participants or researchers are exposed to safety risks other 
than those outlined in this document.  
The study may be terminated in the event natural disasters, widespread outbreak of illness, 
compromised structure of the investigation site, etc. that would make continuation of the study 
impossible or impractical. The study will be suspended within 5 days of determination that the 
study or device put participants at an unreasonable risk.  
If a participant is suspended, terminated, or withdraws from the study, their data can be traced 
with their unique study identification number.  
According to the FDA, follow-up is required for participants who experience Serious Adverse 
Events. Follow up will be conducted by the study manager and/or the PI until the nature of the 
event is resolved. 
 
19 
Publication policyThe clinical investigation will be registered in clinicaltrials.gov, a 
publicly accessible database, as required by U.S. regulations.  
The results of the clinical investigation will be published on clinicaltrials.gov no later than one 
calendar year following the final participant appointment.  
An internal report of the results of this investigation will be completed and uploaded to eQMS.