Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology- Trial to Success Rate
Phase: NA
Conditions: Hearing Loss
Sponsor: Sonova AG

Study Protocol and Statistical Analysis Plan 
Evaluation of New Fitting Characteristics for 
Extended Wear Hearing Aid Technology 
Version 1.0 
March 16, 2022 
NCT05274165 

 
 
Protocol Title 
 
See cover page of original CIP 
 
1 
Background    
Since its original launch in 2008, the Lyric device has offered hearing impaired patients an invisible and 
more convenient option when compared to conventional daily wear hearing aids. Designed to be worn 
in the ear canal for several weeks or months at a time, this extended wear, non-custom hearing aid has 
gone through several iterations and product improvements in the last decade. These product improve- 
ments included an expanded size offering in 2017. However, even with this expanded size offering, 
discomfort, migration, feedback and sound quality continue to be reasons for trial cancellations. These 
issues are often caused by a less than ideal fit, especially if a patient has a conical shaped, or narrowing, 
ear canal. This study aims to evaluate the Trial-to-Success Rate for devices that have modified seals with 
additional sizes, compared to the conventional or current offering of seal sizes. 
 
 
2 
Objectives 
The primary objective is to determine if the availability of additional Lyric sizes results in a higher TSR for 
new Lyric patients as compared to new patients who are offered only traditional sizes. 
Safety objective is to track and document any adverse events related to the investigational device and 
the study procedure. 
 
 
3 
Description of the investigational device 
The Lyric4 device is an analog hearing instrument that is deeply inserted in the ear canal. It consists of 
an electronic module and two seals, a medial and lateral, glued onto the electronic module. 
The overall intended purpose of the device is to amplify and transmit sound at the ear and thereby 
compensate for impaired hearing. The investigational device is made of the same components as the 
commercially available Lyric4 device, but allows for different seal sizes. This may improve the comfort 
and lead to increased fittings and subscriptions. 
 
4 
Design of the clinical investigation 
This exploratory study will have two conditions (Lyric4 only and Lyric4+Modified Seals) across a sample 
of 40 human subjects, 20 in each group. The participant placement will be counter- balanced to ensure a 
variety of ear canal sizes and shapes in both groups, and the participants will be blinded to the devices. 
 
5 
Risks and benefits of the investigational device and clinical investigation 
There are minimal risks associated with both the investigational device and participating in the clinical 
investigation. Identified risks are no greater than those associated with the daily use and wear of 
approved, available hearing aids. The device used presents non-significant risk per FDA.  
The benefits of participating in the investigation include the possibility of hearing sounds that have not 
been previously heard, such as speech and environmental sounds, which may improve communication 
in daily life. Subjects may experience the benefit of personal satisfaction for participating in research to 
improve hearing instrument technology. Subjects will also be compensated for their time in participating 
in this study. 

There are no known or anticipated risks to subject hearing ability associated with participation in this 
study. All sounds used in this study will be presented at safe listening levels. While using hearing aids, 
the following are possible occurrences: 
 
•Cerumen impaction 
 
•Ear discomfort, pain or soreness 
 
•Sweat or moisture accumulation in the ear canal or pinna 
 
•A feeling of pressure or fullness in the ear 
 
•Itching, blisters, or sores in the ear canal or pinna 
 
•Headache 
 
•Redness of tissue 
The research personnel will review these risks with the subjects and answer any questions they have. 
Hearing aids are not a significant risk investigational device as defined in the FDA 21 CFR 812.3(m). 
 
6 
Endpoints 
To satisfy the primary objective, a subjective questionnaire will be administered to each participant after 
the 30 day trial period, before devices are removed. Question domains will focus on intent to purchase, 
but may also include topics on comfort and sound quality. 
 
7 
Inclusion and Exclusion Criteria 
Inclusion criteria: 
-Mild to moderate bilateral hearing loss 
-Ear canal length minimum of 4 mm 
-Ear canal geometry such that a Lyric device can fit comfortably and is deemed an appropriate fit by the 
clinician 
-Meets all other candidacy requirements listed on the Lyric Candidacy form (exclusions below) 
-18+ years 
-Willing to trial devices for 30 days with the knowledge they may not be able to purchase 
Exclusion criteria: 
-History of radiation therapy to the head or neck 
-Middle ear conditions such as TM performation, PE tubes, or cholesteotoma 
-Requires regular MRI testing which would occur during study period 
-Unable or unwilling to tolerate the physical fit of a Lyric devie 
-Inability or unwilling to be seen for 3-4 lab visits 
 
8 
Measurements and procedures 
Patients who meet the Lyric candidacy criteria will be put into one of two groups. The control group will 
be offered only the currently available sizes of Lyric, which is representative of the current commercial 
offering for Lyric. The experimental group will be offered all current sizes as well as the additional sizes. 
Participants will be fit with the most appropriate size available to them in their group. Participants can 
be re-fit with a different size within that group if the initial device is not the best fit. After a 30 day trial 
period, participants will be given specific cost details and asked about their intent to purchase, before 
being told which device they were wearing. Simulated TSR for each group will be calculated based on 
the participants’ intent to purchase. 
All analysis of the results will occur at the conclusion of the study. All study data will be stored digitally. 
The data will be collected from the participants using paper questionnaires or an online survey tool (i.e. 
Alchemer) and then stored in an excel file for analysis. Collection of the questionnaire results will occur 

on an ongoing basis. The lead investigator will scan any paper questionnaires and send them to the 
study monitor via email. All original copies of the questionnaires will be stored at the investigation site. 
 
9 
Statistical design and analysis 
A priori sample size estimation was not performed for this investigation, as the investigation is 
exploratory and does not aim to confirm any effect with statistical significance and power. Due to the 
exploratory nature of this investigation, an informal exploration of the data will be performed at the 
conclusion of the trial. No further statistical analysis is planned. 
 
10 
Investigation Duration 
The investigation is expected to have a total duration of 6-8 months. The expected duration for each 
participant is approximately 30 days.  
 
11 
Data handling and management 
Electronic or paper based CRFs will be used to capture the participant data. If electronic,  subjective 
questionnaires will be available in the EDC system and the participant will be able to read question and 
choose answer. If paper based subjective questionnaires are used, the participant will answer each 
question and the results will be transferred to the EDC by the investigator. Objective data will either be 
entered in directly to the EDC system, or transferred from a paper based CRF into the EDC system.  
All CRFs are kept current to reflect the subject’s status at each phase during the course of study. 
Participants cannot be identified in the CRF by name or initials and birth date but an appropriate coded 
identification is used. All study team members are authorized for the CRF entries and it is assured that 
any authorized person can be identified both for pCRFs and eCRFs. If pCRFs are used, the investigator’s 
initials and subject ID are documented and data are entered into an electronic file for analysis by the 
respective investigator and data will be monitored by the assigned monitor. In case of a self-evident 
corrections, either the subject does it by himself or the investigator undertakes the correction by 
crossing out the word/sentence with a single horizontal line and by adding the correction including his 
personal identifier and the date. 
The pCRFs/eCRFs are only available to the local study team and to the monitor of the study. 
In the case of an audit or a serious adverse event, the CRFs may need to be de-anonymized and sent to 
the governing body (i.e FDA)  or insurance company.  
Any paper-based data will be stored in a locked filing cabinet at the investigation site. All electronic data 
will be stored on an access-restricted server owned, operated, and maintained by Sonova USA. Servers 
used to store data in this investigation are physically located in the US. Permission to access data will be 
limited to study manager, monitor, PI, and essential research staff, as designated by the principal 
investigator.  
The extent and nature of monitoring appropriate for the clinical investigation including the strategy for 
source data verification (SDV) are based on considerations such as the objective, design, complexity, size 
critical data points and endpoints of the clinical investigation. A de-tailed plan for monitoring 
arrangements is provided separately from this CIP. 
 
12 
Amendments to the CIP 
Any necessary amendments to the CIP will be communicated to the study manager/sponsor. 
A new version of the CIP will be written, with the necessary changes and justification, and the PI will be 
trained on the amendments. 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. 

 
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 
Sonova, in its capacity as sponsor, will maintain a log of all investigational devices, including the date of 
shipment from Sonova to the site, serial number, receiving study site, and date returned to Sonova. 
The site will maintain a log of the devices provided by Sonova, including the date of receipt,serial 
number, date of fitting, participant identification, date of return to site by participant, and date returned 
to Sonova. Sonova will provide each site a template with which to record such information. 
If a device needs to be replaced due to a device deficiency, the PI or sub-investigator will add the new 
device serial number, date of receipt, and date of return of the defective device on the Device 
Accountability Log. 
In the case of a device deficiency, the Adverse Event-Device Deficiency form will be completed by the 
study manager and the PI or sub-investigators together. 
 
15 
Informed consent process 
Informed consent will be obtained from participants prior to any study participation in accordance with 
the IRB guidelines. The participants will be granted sufficient time to read through the consent in full 
and ask any questions they have before signing. After the participant signs the consent form, the 
researcher will sign and provide a copy to the participant. This process will take place in a private office 
located in the sub-investigator’s clinic. 
 
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 consent 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 policy 
The 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.