Evaluation of Hearing Aid Benefit

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural
• Interventions: Device: New hearing aid

• Registration Number: NCT05198713
• Lead Sponsor: Sonova AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Study Start: 2022-01-18
• Study First Posted: 2022-01-20
• Primary Completion: 2022-03-04
• Study Completion: 2022-03-04
• Results First Submitted: 2023-04-12
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Results First Posted: 2023-06-06
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	New hearing aid	All participants will be fit with the study hearing aid and under go the same testing conditions.

Primary Outcome Measures

Name	Time	Method
Speech Intelligibility in Quiet.	Day 1 and Day 15	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.

Secondary Outcome Measures

Name	Time	Method
Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words	Day 1 and Day 15	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.

Trial Locations

Locations (1)

Phonak Audiology Research Center; 🇺🇸 Aurora, Illinois, United States