Clinical Study of Released Unitron RIC (Receiver in Canal) and BTE (Behind the Ear) Hearing Aid Models
Phase: NA
Conditions: Hearing Loss
Sponsor: Sonova AG

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Study Protocol and Statistical Analysis Plan 
Clinical Study of Released Unitron RIC and 
BTE Hearing Aid Models – ID# 515 
January 4, 2022. 
NCT05197803 

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Clinical Study of Released Unitron RIC and 
BTE Hearing Aid Models – ID# 515
1 Objectives and hypotheses of the clinical investigation 
1.1 Purpose of the clinical investigation claims for clinical performance, effec-
tiveness or safety of the investigational device that are to be verified 
This clinical study intends to show that compared to the unaided condition, the released 
Unitron RIC and BTE hearing aid models provide amplification that will improve speech intel-
ligibility when programmed for individual hearing losses. The study (and the resulting clinical 
data) will support the clinical benefit claim: “improved speech understanding” necessary to 
update the CER which is necessary for the CE submission. The claim will not be use externally 
or in any marketing material. 
1.2 Primary and Secondary Objectives 
The primary objective of this study is to confirm the improvement in the speech understanding 
with the released Unitron RIC and BTE hearing aid models in 20-25 participants with mild to 
severe hearing loss in a sound room/lab setting; testing will be performed with a standardized 
speech discrimination test – HINT in noise and the data will be collected during one-time visit. 
2 Design of the clinical investigation 
2.1 General 
2.1.1 Design Type 
This is a confirmatory study using a single group, unblinded in a single site. The data will be 
collected during one-time visit and results for each form factor will not be compared against 
each other but only against the unaided condition. 
2.2 Procedures 
2.2.1 Investigation-related Procedure 
Participants will be selected from the existing database and based on their hearing loss; in-
clusion/exclusion criteria will be discussed. If necessary, an updated hearing test will be con-
ducted prior to the start of data collection. Participants will be contacted via email and/or call 
to set up a time for the one-time visit. During the visit, participants will sign the consent form, 
they will be fit with the released Unitron RIC and BTE hearing aid models, and perform the 
HINT test in the sound room for the three study conditions: unaided, aided with RIC, and aided 
with BTE.  
3 Statistical design and analysis 
3.1 Determination of Sample Size 
Although we have no prior data showing an estimated mean difference between unaided and 
aided conditions, we looked at the literature to estimate aided vs unaided benefit.  
Valente & Mispagel (2008) investigated unaided and aided (Omni and Directional) HINT per-
formance in adults with a sloping normal to moderately-severe SNHL. Results had shown that 
aided-directional HINT performance was significantly better than both unaided or aided-omni 

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conditions. The mean difference (1.7 dB) and SD (2.4) between unaided and aided-directional 
performance were used for the power analysis and ultimately calculating sample size. 
Power Analysis was done using the G*Power Software (Faul et al., 2007). Power analysis was 
done for a one-tailed dependent t-test between two means. The table below list the input pa-
rameters used to calculate sample size. 
Input parameters 
Output parameters 
•
Mean of differences: 1.7
•
SD of differences: 2.4
•
Effect size dz: 0.708
•
Alpha=0.05
•
Power=0.95
•
Non centrality parameter: 3.40
•
Critical t: 1.72
•
Actual power: 0.95
•
Df: 22
•
Total sample size: 23
Based on the above calculations, it was determined that a minimum of 23 participants will be 
required based on a power analysis using arms-length data.  
3.2 Statistical criteria of termination of trial 
There is no statistical criteria that would cause termination of the trial. 
3.3 Planned Analysis 
The data analysis will be done upon completion of data collection. A one-tailed t-test will be 
done as part of the analysis. 
3.3.1 Datasets to be analyzed, analysis population 
•
Analysis population: 20-25 participants
•
Data sets:
o
Unaided vs. aided with RIC.
o
Unaided vs. aided with BTE.
3.3.2 Primary Endpoint Analysis 
The data will be entered in a Microsoft Excel spreadsheet for analysis. The statistician as-
signed will analyze the data to determine statistical significance between conditions if present. 
3.3.3 Secondary Endpoint Analysis 
Non applicable. 
4 Informed consent process 
4.1 Process for obtaining informed consent 
Participants are required to sign a consent form prior to participation in the study. The consent 
form will be provided at the time of their first appointment and relevant tick boxes for this 
particular study will be noted. Participants will consent by writing their names and signature 
and will include the name of the researcher obtaining consent. The document will be converted 
into a PDF and will be uploaded into the database. The paper forms will be stored in a secured 
cabinet only accessible by the researchers.