Evaluation of Hearing Aid Benefit

Hearing Loss, Sensorineural Clinical Trial

Official title:

Evaluation of Hearing Aid Benefit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05198713
• Other study ID #: SRF-487
• Status: Completed
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: March 4, 2022

Study information

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

Clinical Trial Summary

The present study will investigate the benefit of hearing aids for speech intelligibility (in both quiet and noisy environments) compared to the unaided condition. Participants will include adults with moderate to moderately severe hearing impairment. The participants will complete laboratory-based speech intelligibility assessments with binaural hearing aids and without hearing aids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 4, 2022
• Est. primary completion date: March 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Moderate to moderately severe sensorineural hearing loss

• Willingness to wear custom hearing instruments during the study.

• Age-normal cognition

• Ability to attend on-site study visits.

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• New hearing aid
Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.

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	Speech Intelligibility in Quiet.	Speech intelligibility for monosyllabic words presented in quiet. The words are presented at a fixed level and the percentage of words correctly repeated is calculated. A higher percentage is better. This was done in both unaided and aided conditions.	Day 1 and Day 15
Secondary	Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words	Speech intelligibility on key words for sentences presented in noise. Noise is presented at a fixed level, and the words are presented at adaptive levels, below and above the noise level. A negative number is better, because it indicates the participant can correctly repeat 50% of the words when the words are below the level of noise. This was done at baseline in the unaided condition on Day 1 of the study, and in the aided condition on Day 15.	Day 1 and Day 15