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NCT04787055 Clinical Trial

In Field Performance of a Hearing Aid Transducer

Hearing Loss Clinical Trial

Official title:
A Study to Examine the Performance of a Hearing Aid Transducer During Typical, In-field Use

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04787055
Other study ID # SRF-61
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date December 31, 2021

Study information
Verified date May 2022
Source Sonova AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study participants will be fit with previously released receiver-in-canal (RIC) hearing instruments. Participants will be asked to wear the instruments in their daily life for a minimum of 3 months, but have the option to continue to wear devices for six months.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date December 31, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Mild to moderate sensorineural hearing loss - Adult Exclusion Criteria: - Inability or unwillingness to wear study devices for extended period of time.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Receiver-in-canal hearing instrument
Receiver-in-canal hearing instrument

Locations
Country Name City State
United States Phonak Audiology Research Center Aurora Illinois

Sponsors (1)
Lead Sponsor Collaborator
Sonova AG

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective Satisfaction of Hearing Aid Performance in Noisy Environments Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. Three months after initial appointment
Primary Subjective Satisfaction of Hearing Aid Performance in Noisy Environments Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. Six months after initial appointment
Primary Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. Three months after initial appointment
Primary Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. Six months after initial appointment
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