A Study to Examine the Performance of a Hearing Aid Transducer During Typical, In-field Use
Phase: NA
Conditions: Hearing Loss
Sponsor: Sonova AG

Study Protocol  
 
 
A Study to Examine the Performance of a 
Hearing Aid Transducer During Typical, In-field 
Use 
 
 
Version 2.0 
Original 07/24/2020 
Updated format 02/23/2023 
 
 
 
 
NCT04787055 
 
 
 

 
 
 
In Field Performance of a Hearing Aid Transducer 
1 Background 
Hearing aid vents serve three primary purposes. The first purpose of a vent is to 
allow low-frequency sounds to pass directly into the ear, taking advantage of any 
residual low-frequency hearing ability. Vents also provide a level of comfort to the 
wearer by maintaining equal pressure with the space outside the ear. Finally, 
because vents allow for the escape of amplified sound out of the ear, they reduce 
the perception of occlusion for the wearer. However, while vents can provide 
improved sound quality and comfort, there are certain conditions in which a more 
closed fit would result in better sound quality and hearing performance, such as in 
noise and with streaming. This study will evaluate the sound quality in these 
situations with a prototype receiver which houses a dynamic venting system. 
Because this prototype is a new concept, this study serves to investigate topics such 
as overall reliability and end user perception.   
2 Objectives 
The purpose of this study is to evaluate the sound quality and reliability of a prototype 
receiver for RIC hearing aids.  
3 Description of the investigational device 
This study will use commercially available Phonak Marvel RIC hearing aids with a 
prototype dynamic receiver transducer. As the receiver is a prototype, no detailed 
description will be shared in a publicly viewed database. 
4 Design of the clinical investigation 
This a single-site, single group prospective, interventional study using commercially 
available Receiver-In-Canal hearing aids with a prototype receiver. Participants will 
be asked to participate in a three month long home trial. Following the three month 
trial, new participants will be recruited to participate in a six month home trial. 
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 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. Additionally, participation in this study will 
help to inform future developments and improvements in hearing device technology. 
 
Subjects experience the benefit of personal satisfaction for participating in research 
to improve hearing instrument technology, which has the potential to make future 
hearing aid use more beneficial and convenient. 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 the study. All sounds used in this study will be presented at safe 
listening levels. 
While using the study hearing aid, the following are possible occurrences: 
• Cerumen impaction 
• Discomfort, pain, or soreness 
• Sweat or moisture accumulation in the ear canal or pinna 
• A feeling of pressure or fullness in the ear 
• Blisters, itching, sores, or rashes in the ear canal or pinna 
• Headache 
• Redness of tissue 
 
The research personnel will review all of these risks with the subjects and answer 
any questions they have. 
This is a non-significant risk study following the abbreviated IDE requirements set 
forth in 21 
C.F.R. § 812.2 (b)(1). [Hearing Aid] is not a significant risk investigational device as 
defined in 21C.F.R. § 812.3 (m). 
 
6 Endpoints 
Subjective ratings of sound quality in noise will be collected from the participants at 
the end of the three month trial, and from participants at the end of the six month trial. 
Reliability of the prototype receivers will also be recorded. 
7 Inclusion and Exclusion Criteria 
Inclusion criteria are as follows: 
 
-Individuals over the age of 18 with mild to moderate symmetric hearing loss 
 
-Experienced hearing aid users 
 
-Willing to wear hearing aids for 12-16 hours per day for 3 to 6 months 
 
-Able and willing to use smartphone (or other device) to stream media and 
phone calls to hearing aids. 
 
Exclusion criteria are as follows: 
 

 
-Anyone self reporting ear-related pathology, including otorrhea within 90 
days, dizziness, sudden onset or worsening of hearing loss within 90 days, 
visible deformity of the ear, or otalgia 
 
-Hearing loss that is too severe or too mild to be included in the recommended 
fitting range of the hearing devices 
 
-New/inexperienced users 
 
-Unable or unwilling to wear devices for specified period of time 
 
-Recent history of middle e 
 
8 Measurements and procedures 
Participants will be given a hearing test if the most recent test on file is greater than 
12 months. 
Hearing aids will be fit and programmed according to best practices and adjusted for 
patient comfort, if necessary. 
Participants will wear devices for either a 3 month period or a 6 month period, and 
will use the hearing aids as they would in daily life. Researcher will check in on a 
regular basis with each participant to ensure that device appears to be functioning 
and working properly. Additionally, participants will return to the lab on a regular basis 
for hearing aid checks. 
At the end of the three or six month period, participants will be given a questionnaire 
asking them to rate their satisfaction with the performance of the devices. 
Additionally, participants may be asked if they would purchase devices and what they 
would expect a purchase price to be. 
Researcher will record any deficiencies found with the prototype receivers and 
transmit information to the study requestors and product engineers. 
9 Statistical design and analysis 
There will be no statistical analysis of results. The average satisfaction ratings for 
sound quality in noise will be reported to the product manager. The reliability of the 
prototypes will also be recorded, and information will be sent to the engineers in the 
Research & Development department. Survival rate of the prototypes may be 
calculated by the R&D personnel in order to inform the future development of the 
prototype. 
10 Investigation Duration  
Participants will be expected to participate for either 3 months or 6 months. The 
entire investigation will take approximately 12 months to complete. 
11 Data Handling and Management 
Electronic or paper based CRFs will be used to capture the participants’ answers to 
the subjective questions. If electronic, the questionnaire will be available in the EDC 
system and the participant will be able to read the question and choose the answer. If 

paper based, the participant will answer each question and the results will be 
transferred to the EDC by the investigator. 
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. 
The Sponsor and Principal investigator affirm and uphold the principle of the 
participant's right to  privacy  and that they shall  comply  with  applicable  privacy  
laws.  Specifically, anonymity of the participants shall be guaranteed when presenting 
the data at scientific meetings or publishing in scientific journals. Individual participant 
medical information obtained as a result of this clinical investigation is considered 
confidential and disclosure to third parties is prohibited.  
 
All participants will be assigned an alphanumeric code by the PI and/or sub-
investigators. Data shared with the study manager or monitor will be anonymized. 
The de-identified data will be kept for 10 years after the publication of the results. 
Any identifiable information, such as the Subject ID Log, will be kept in a secure 
location at the investigative site. In the case of external studies, the sponsor/study 
manager, and monitor will not have permission to save, store, record, retain, or share 
any identifiable information. The monitor will only view the informed consents in the 
presence of the study investigator (either via screen share if remote, or in person) for 
purposes of fulfilling ethical obligation to participant rights and safety. 
 
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 HQ  to the site, serial number, receiving 
study site, and date returned to Sonova. 
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 
Phonak Audiology Research Center. 
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 seriousness 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) until the nature of the event is resolved. 
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. 
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. 
17 Vulnerable Populations 
There are no vulnerable populations included in this study. 
18 Suspension or premature termination of the clinical investigation 
The study will be suspended or terminated if the majority of the participants are not 
able to wear the devices on a daily basis. 

The study will be suspended or terminated if the feature and/or investigative device 
malfunctions or 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 (per 212 CFR 812). 
19 Publication policy 
The clinical investigation will be registered in clinicaltrials.gov, a publicly accessible 
database, as required by US regulations. 
The results of the clinical investigation will be published as an internal study report.