Evaluation of the Clinical Benefit of the Hearing Aids Tinnitus Feature.
Phase: NA
Conditions: Hearing Loss, Sensorineural, Tinnitus
Sponsor: Sonova AG

 
 
 
 
Study Protocol and Statistical Analysis Plan 
 
Evaluation of the Clinical benefit of the hearing aids tinnitus feature – 
ID# 481 
April 5, 2024 
 
NCT05292534 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Evaluation of the Clinical benefit of the hearing aids tinnitus feature – 
ID# 481 
 
 
1 Objectives and hypotheses of the clinical investigation 
1.1 Purpose of the clinical investigation claims for clinical performance, 
effectiveness or safety of the investigational device that are to be verified 
This clinical study was conducted with commercially available hearing devices to verify the clinical 
benefit of a haring aids tinnitus feature. The study (and the resulting clinical data) could support the CER 
for claims purposes. 
1.2 Primary and Secondary Objectives  
The primary objective of this study is to evaluate the clinical benefit of a noiser feature for tinnitus relief 
in 30 participants with mild to moderate sensorineural hearing loss and chronic bothersome tinnitus. 
2 Design of the clinical investigation 
2.1 General 
2.1.1 Design Type 
This is a randomized, cross-over confirmatory study with participants serving as self-controls. Tinnitus 
Functional Index questionnaire (TFI) will be the outcome measurer, administered at baseline (before 
study intervention), and after each study condition. Baseline TFI will be compared to that after each 
study condition. 
There are two intervention conditions (duration of 4 weeks each): amplification-only, and 
amplification+noiser, followed by the same period (4 weeks) of intervention withdrawal. 
The outcome measurer (TFI) will be administered before and after each study condition. 
2.2 Procedures 
2.2.1 Investigation-related Procedure  
Participants will be recruited from the overall population based on their hearing loss and tinnitus 
intrusion levels; Inclusion criteria include: mild to moderate sensorineural hearing loss, chronic 
(3+months) bothersome tinnitus (determined by TFI equal or greater than 20 points at baseline), 
confirmed tinnitus stability with 2 consecutive TFI measures of at least 2 weeks apart, minimum age of 
18 years old, no previous experience with hearing aid amplification. Participants will undergo a 
screening session to confirm study eligibility. 

Participants will sign the consent form and complete the demographic questionnaire prior to being 
assigned randomly to their first intervention condition with a hearing aid fitting (with or without a 
masking noiser). 
Visit 1: hearing screening, demographic information collection, first TFI screening. 
 
Visit 2: between 2 and 4 weeks after the 1st visit, to verify tinnitus stability (via 2nd TFI 
measurement). If TFI confirms stable Tinnitus condition, participant will be randomly assigned to one 
intervention condition and can be fit with hearing aids on the same session. 
Visit 3: TFI administration, and second intervention condition set up 
Visit 4: TFI administration and devices will be returned 
Visit 5: TFI administration 
3 Statistical design and analysis 
3.1 Determination of Sample Size 
We will recruit 30 participants in total;  
3.2 Statistical criteria of termination of trial 
n/a 
3.3 Planned Analyses 
3.3.1 Datasets to be analyzed, analysis population 
TFI scores will be analysed before and after each intervention condition within study participants. 
3.3.2 Primary Analysis 
Repeated Measures ANOVA will be used to detect significant effects with amplification-only and 
amplification+noiser as fixed effects variables, and participants as a random effects variable. Post-hoc 
pairwise t-tests will identify further differences. 
3.3.3 Interim Analysis 
Within 48 of each intervention condition set up time, and again at 2 weeks after each intervention 
condition set up, the study team will contact each participant to address any questions or issues they 
may have, and an office visit will be offered if needed.  
 
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. Participants are asked to review the entirety of the 
form and ask questions about the content in the form, if any. Participants consent by writing their 
names and signature.