Hearing Aid Quality and Reliability Study

Hearing Loss Clinical Trial

Official title:

Hearing Aid Quality Check and Reliability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04995666
• Other study ID #: SRF-368
• Status: Completed
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will wear hearing aids daily for approximately 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 31, 2021
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adults with mild to moderate severe sensorineural hearing loss

• Adults who were able to incorporate some type of physical activity into their day (i.e walking, excercise, gardening, etc.)

Exclusion Criteria:

• Unable or unwilling to wear study devices during a home trial

• Unable or unwilling to come to lab for study visits

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Phonak Audeo hearing aid
Rechargeable hearing aid

Locations

Country	Name	City	State
United States	Sonova	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	Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 1	Test box electroacoustic measurements of hearing aid done at full on settings must meet manufacturer product specifications per manufacturer data sheet. This includes maximum and high frequency average output sound pressure level, maximum and high frequency average acoustic gain, frequency response range, total harmonic distortion and equivalent input noise level. This is done using an Audioscan Verifit2 electroacoustic analyzer.; Electroacoustic measurements listed above will also be taken with hearing aid set to user settings, as a baseline measure for all future appointments.	Day 1 of study
Primary	Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 45	Test box electroacoustic measurements (using the Audioscan Verifit 2 Electroacoustic Analyzer) of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).	Day 45 of study
Primary	Electroacoustic Evaluation of Hearing Aids in Accordance With Manufacturer Specifications, Day 90	Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Test box electroacoustic measurements of hearing aid done at user gain settings after daily use for extended period of time. Results will be compared to baseline electroacoustic measures taken on day 1 of study. A "pass" means that devices were within tolerance levels (per ANSI S3.22-2014) of baseline measures. A "fail" means that devices were not within tolerance levels of one or more baseline measures (i.e. output, gain, frequency range, total harmonic distortion, or equivalent input noise level).	Day 90 of study