Evaluation of Hearing Aid Benefit
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2022
CompletedStudy Start
First participant enrolled
January 18, 2022
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2022
CompletedResults Posted
Study results publicly available
June 6, 2023
CompletedJune 6, 2023
May 1, 2023
2 months
January 5, 2022
April 12, 2023
May 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
Experimental
EXPERIMENTALAll participants will be fit with the study hearing aid and under go the same testing conditions.
Interventions
Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Phonak Audiology Research Center
Aurora, Illinois, 60504, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Research
- Organization
- Sonova US Corporate Services, LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Seitz-Paquette, AuD
Sonova AG
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2022
First Posted
January 20, 2022
Study Start
January 18, 2022
Primary Completion
March 4, 2022
Study Completion
March 4, 2022
Last Updated
June 6, 2023
Results First Posted
June 6, 2023
Record last verified: 2023-05