Hearing Aid Transmitter Performance Study - SRF-366

Hearing Loss Clinical Trial

Official title:

Hearing Aid Transmitter Performance Study - SRF-366

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774185
• Other study ID #: SRF-366
• Status: Completed
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: April 25, 2022

Study information

• Verified date: April 2021
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• New hearing aid loudspeaker
The new hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
• Standard hearing aid loudspeaker
The standard hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.

Locations

Country	Name	City	State
Australia	National Acoustic Laboratories	Sydney

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of speech intelligibility and sound quality for different loudspeaker	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)".	2 weeks
Secondary	Evaluation of listening effort for different loudspeaker.	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".	2 weeks
Secondary	Evaluation of sound quality of own voice for different loudspeaker.	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)".	2 weeks
Secondary	Evaluation of sound quality of streamed signals for different loudspeaker	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)".	2 weeks

External Links

•   ActiveVent™ Receiver provides benefit of open and --closed acoustics for better speech understanding in noise and naturalness of own voice perception