Hearing Aid Transmitter Performance Study - SRF-366

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: New hearing aid loudspeaker; Device: Standard hearing aid loudspeaker

• Registration Number: NCT04774185
• Lead Sponsor: Sonova AG

Brief Summary

Sonova Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Sonova Hearing Systems undergo a final quality control in terms of clinical trials. This is a confirmatory study, investigating benefits of a modified hearing aid loudspeaker. This will be a clinical investigation which will be conducted mono centric at National Acoustic Laboratories a well known institution with exceptional experience (Australia).

Detailed Description

In this study a comparison with two Phonak Receiver in Canal (RIC) devices is done. The experimental device with a modified hearing aid loudspeaker concept and the active comparator with the existing technology will be compared regarding speech intelligibility, listening effort and sound quality in speech in noise, quiet situations for people with mild to moderate hearing losses.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Status Verified: 2021-04
• Study Start: 2021-04-26
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss)
• Good written and spoken English language skills
• Healthy outer ear
• Ability to fill in a questionnaire (p/eCRF) conscientiously
• Willingness to wear Receiver in Canal hearing aids
• Informed Consent as documented by signature
• Normal cognitive abilities

Exclusion Criteria

• Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
• Limited mobility and not in the position to attend weekly appointments in Sydney (AUS)
• Limited ability to describe listening impressions/experiences and the use of the hearing aid
• Inability to produce a reliable hearing test result
• Known psychological problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
New hearing aid loudspeaker	New hearing aid loudspeaker	The new hearing aid loudspeaker is a loudspeaker system with a modified acoustic coupling approach which will be fitted based on the participants' individual ear anatomy.
Standard hearing aid loudspeaker	Standard hearing aid loudspeaker	The hearing aid loudspeaker is a loudspeaker system with the existing acoustic coupling approach which will be fitted based on the participants' individual ear anatomy.

Primary Outcome Measures

Name	Time	Method
Evaluation of speech intelligibility and sound quality for different loudspeaker	2 weeks	The Primary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to speech intelligibility in a noisy environment and sound quality in a quiet situation.; The speech intelligibility will be measured using a speech test in dB SRT and the sound quality will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".

Secondary Outcome Measures

Name	Time	Method
Evaluation of sound quality of streamed signals for different loudspeaker	2 weeks	The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to sound quality of a streamed signal in quiet and noise..; The sound quality of the streamed signal will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".
Evaluation of listening effort for different loudspeaker.	2 weeks	The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to listening effort in a noisy environment.; The listening effort of speech will be assessed by subjective rating, within 13 steps, from "not effortful at all" to "only noise".
Evaluation of sound quality of own voice for different loudspeaker.	2 weeks	The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to sound quality in quiet.; The sound quality of own voice will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".

Trial Locations

Locations (1)

National Acoustic Laboratories; 🇦🇺 Sydney, Australia