Evaluation of Fitting Modification for Extended Wear Technology
Phase: NA
Conditions: Hearing Loss
Sponsor: Sonova AG

Study Protocol and Statistical Analysis Plan 
 
 
Evaluation of Extended Wear Technology 
 
 
V 2.0 
December 20, 2021 
 
 
 
 
NCT04882800 
 
 
 
 
 

Evaluation of Extended Wear Technology 
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 improvements included an expanded size 
offering in 2017. However, even with this expanded size offering, discomfort, migration, 
feedback and sound quality still account for a large number of trial cancellations. These 
issues are often caused by a less than ideal fit, especially if a patient has narrowing ear 
canal. 
2 Objectives 
The primary objective is to determine if patients who have rejected or cancelled Lyric 
subscriptions within the last two years due to discomfort or feedback, migration or poor 
sound quality (due to poor fit) rate the investigational Lyric4 devices with a fitting 
modification as more comfortable  than the conventional Lyric4 devices.   
There are no secondary objectives. 
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. Currently, the Lyric4 is available in seven non-custom sizes: XXS, XS, 
S, M, L, XL,  and XXL. The investigational device is made of the same components of the 
commercially available Lyric4 device, but with a fitting modification which may allow for 
an improved fit for narrower ear canals and increase the size options.  
4 Design of the clinical investigation 
This will be an interventional, single group design with two conditions (Lyric4 and Lyric4 
with fitting modification) where subjects will wear the currently available Lyric device in one 
ear and the investigational device in the opposite ear for two weeks; and then switch ears 
for two additional weeks. Subjects will be blinded as to which device is in each ear. 
5 Risks and benefits of the investigational device and clinical 
Investigation 
The product-related risks and the clinical investigation procedure-related risks are well-
controlled during the clinical investigation as the subject is under the care of a well-
established, Lyric-trained, hearing health care provider. Any ear health risk from this 
investigation is no greater than any risk a hearing impaired patient experiences when 
undergoing a Lyric trial with a certified Lyric provider. 
The study may reveal that the investigational devices are more comfortable for those 
patients who were unable to wear Lyric devices previously, thus implying an improved fit 
rate. The investigational devices are not custom, and do not require extensive 
modifications of the Lyric component itself. If improved fit rate can be confirmed, it is 

likely that more hearing impaired patients who would like to experience the benefits of an 
extended wear device would be able to do so. 
6 Endpoints 
To satisfy the primary objective, subjective questionnaires will be administered after each 
device fitting and removal. Question domains may include, but are not limited to, comfort, 
occlusion, feedback, sound quality, and purchasing interest. 
7 Inclusion and Exclusion Criteria 
Inclusion criteria: Hearing loss N2-N4 (mild to moderate) 
 
 
 
Hearing impairment: Any (conductive or sensorineural) 
 
 
 
Population: Adults 
 
 
 
Minimum Age: 18 years 
 
 
 
Maximum Age: 90 years 
Other:  
 
Previous Lyric users who rejected or cancelled Lyric trials or  
 
 
subscriptions due to discomfort, feedback, migration, or poor sound  
 
 
quality due to fit issues.  
Exclusion criteria: Participants who can only wear a size XXS Lyric will be excluded as  
 
 
even an XXS investigational device would likely not be any more  
 
 
beneficial than a conventional XXS Lyric4 device.  
 
 
 
Asymmetrical hearing loss 
 
 
 
Other diagnosis that may cause fluctuations in hearing (i.e. Meniere’s 
 
 
disease) 
 
 
 
Unable to tolerate the physical fit of a Lyric device 
 
 
 
Inability to be seen for 4 lab visits 
 
8 Measurements and procedures 
Investigation related procedures: 
Study Procedure 
Impact on subject 
Standard of care? 
Audiogram; may be 
done if most recent 
audiogram is more 
than 12 months old 
Assesses hearing loss 
Yes 
Cerumen 
management 
Clears ear canal of wax 
Yes 
Ear mold impression; 
may be done for 
future analysis of ear 
shape  
Takes custom impression of ear 
Yes 

 
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 and then be stored in an excel file for analysis. Collection of the 
questionnaire results will occur on an ongoing basis. The lead investigator will scan the 
paper questionnaires and send them to the study manager via email. All original copies 
of the questionnaires will be stored at the investigation site until the conclusion of the 
study, at which point they will be mailed to the study manager. Only authorized 
research personnel at the sponsor site will have access to the study results. 
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. 
This is an exploratory trial and will not have statistical criteria for termination. 
The experiment performed within this study is designed to evaluate the efficacy and 
effectiveness of new fitting characteristics to the Lyric extended-wear hearing technology 
as compared to the commercially available Lyric device. The statistical hypothesis is that 
average ratings of wearing comfort with the new technology will be equivalent to or better 
than the commercially available technology. A qualitative analysis of the questionnaires 
will be used for data analysis. Qualitative data will be collected as a question, response, 
and anonymous participant ID for all participants at each device fitting and removal. 
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. 
All safety related events will be constantly monitored by the investigators and will 
immediately reported to the Principle Investigator. Evaluation of any SAE, SADE, or 
UADE will be conducted promptly using Sonova’s standard medical device referral 
protocol.  Confirmed UADEs will be reported to the IRB within 10 days after receiving 
notice of the event.  If it is determined that an event or effect presents an unreasonable 
risk to subjects, this study, or those parts of the study presenting that risk, will be 
terminated no later than 5 working days after the determination is made and no later than 
15 working days after Sonova USA first received notice of the event.  
A safety analysis of the relevant data will be done after the data collection is finished. 
 
Deviations to the statistical plan will be captured and reported in an update to this 
document, with justification. 
If data records are complete from subjects who dropped out of the study early, these data 
will also be used in the analysis. If the data sets are not complete, they will not be 
integrated at all. If a subject is dropping out before data collection is finished, the study 
team will try to complete as many data sets as possible. If a subject drops out before the 
first study visit the subject will be replaced if possible. 
Fit with Lyric devices 
Provides prescriptive 
amplification 
Yes 
Questionnaires; will 
be completed after 
each home trial for 
both devices 
Assesses subjective relating to 
the investigational device/feature 
No –These questionnaires were 
designed for this specific study. 
They are not validated for clinical 
outcomes. 

 
10 Investigation Duration  
The investigation is expected to last approximately 8 weeks. The expected duration for 
participation by the subjects is 4-5 weeks. 
11 Data Handling and Management 
Study data is recorded both with paper and with electronic Case Report Forms (p/eCRF). 
For each enrolled study participant a CRF is maintained. 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 acronym as well as the subject ID is filled in and data 
are entered into an electronic file for analysis by the respective investigator and data get 
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. 
Source documents for this investigation include, audiograms, ALPs fitting files, Lyric 
history, including prior adverse events, appointment checklists, and paper copies of the 
subjective questionnaires. 
All paper data will be stored in a locked filing cabinet at the Phonak Audiology Research 
Center (PARC). All electronic data files will be encrypted and stored on secure research 
computers. All identifying data will be stored at the site. De-identified data will be shared, 
if necessary,  with production to cross-check the quality of scans/impressions, and with 
partners at Sonova Switzerland.  
The identifiable data will be destroyed as soon as the final analyses have been 
completed. The de-identified data will be kept for seven years after the publication of 
results. When the data are destroyed, paper records will be shredded by services 
provided at PARC. Electronic data will be encrypted as de-identified NOAH packages, 
where applicable, to be shared with Sonova Switzerland. 
12 Amendments to the CIP 
Amendments to the study plan, if necessary, will be updated with justification in this 
document. 
13 Deviations from clinical investigation plan 
Deviations from the study plan 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 study plan unless that deviation does not 
influence the investigation data. 
 

14 Device accountability 
The sub-investigator at site or authorized designee  will keep records documenting the 
following in a written process: 
• 
Names of participants who received, used, returned, or disposed of device 
• 
Date of receipt, identification, and quantity of each investigational device (batch/serial 
number or unique code) 
• 
Expiry date (if applicable) 
• 
Date(s) of use 
• 
Participant identification 
15 Informed consent process 
At the beginning of the first appointment, the investigator will hand the consent form to 
the participant in a private setting and grant sufficient time to read the whole form. The 
consent form contains detailed information about incentives and reimbursement. Any 
questions will be answered and the participant will be given sufficient time to decide 
whether or not they want to participate in the study. After the participant signed two 
copies of the consent form, the researcher will sign both copies as well and provide one 
copy to the participant. 
In case of changes to the procedures described in the consent form, the participant will 
be informed at the beginning of an appointment. 
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) 
Evaluation of any SAE, SADE, or UADE will be conducted promptly using Sonova’s 
standard medical device referral protocol.   
In the event of an adverse event, the investigation manager will make contact with the 
principal investigator within 24 hours to align on reporting procedures and to evaluate the 
relationship of the investigational device and the related procedure.  
In the event of a serious adverse event, this will be reported to the FDA using Reporting 
Form FDA 3500, or by telephone at 1-800-FDA-1088.  
Confirmed UADEs will be reported to the IRB within 10 days after receiving notice of the 
event.  If it is determined that an event or effect presents an unreasonable risk to 
subjects, this study, or those parts of the study presenting that risk, will be terminated no 
later than 5 working days after the determination is made and no later than 15 working 
days after Sonova USA first received notice of the event.  
A causal relationship towards the medical device or investigation procedure should be 
rated as follows: 

Not related: The relationship to the device or procedures can be excluded. 
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. 
Probable: The relationship with the use of the investigational device seems relevant 
and/or the event cannot be reasonably explained by another cause. 
Causal relationship: The serious event is associated with the investigational device or 
with procedures beyond reasonable doubt. 
Device deficiencies that might have led to an SAE are always related to the medical 
device. 
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 
The investigation does not include any vulnerable populations. 
18 Suspension or premature termination of the clinical investigation 
The clinical investigation will be suspended or prematurely 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. These events may 
include but are not limited to – natural disaster, widespread outbreak of illness, 
compromised structure of the investigation site, etc.  
19 Publication policy 
The clinical investigation will be registered in clinicaltrials.gov, a publicly accessible 
database, as required by US law. 
 
The results of the clinical investigation will be documented internally in a study report with 
the possibility of an online publication.