Back to resultsEvaluation of Hearing Aid Benefit
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
New hearing aid
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural
Eligibility Criteria
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.
Sites / Locations
- Phonak Audiology Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
All participants will be fit with the study hearing aid and under go the same testing conditions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05198713
Brief Title
Evaluation of Hearing Aid Benefit
Official Title
Evaluation of Hearing Aid Benefit
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
All participants will be fit with the study hearing aid and under go the same testing conditions.
Intervention Type
Device
Intervention Name(s)
New hearing aid
Intervention Description
Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.
Primary Outcome Measure Information:
Title
Speech Intelligibility in Quiet.
Description
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.
Time Frame
Day 1 and Day 15
Secondary Outcome Measure Information:
Title
Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words
Description
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.
Time Frame
Day 1 and Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Seitz-Paquette, AuD
Organizational Affiliation
Sonova AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phonak Audiology Research Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
12. IPD Sharing Statement
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Evaluation of Hearing Aid Benefit
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