Effect of Hearing Aid Labeling on Speech Understanding Measures
1 other identifier
interventional
20
1 country
1
Brief Summary
New and experienced hearing aid users will be fit with two hearing devices. One will be labeled as an OTC (Over-The-Counter) device, the other will be labeled as a Prescriptive (i.e. professionally fit) device. Both devices will be generically programmed for a mild to moderate hearing loss. An objective speech in noise test will be completed with both devices.
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 May 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
March 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 10, 2022
CompletedStudy Start
First participant enrolled
May 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2022
CompletedResults Posted
Study results publicly available
July 10, 2023
CompletedJuly 10, 2023
June 1, 2023
21 days
March 1, 2022
May 31, 2023
June 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Quick Speech in Noise Test (QuickSIN)
A speech in noise test in which participant repeats sentences in variable levels of background noise. Test result is reported as the signal to noise level at which participant can repeat 50% of the words correctly. A lower score/dB SNR (decibel Signal to Noise Ratio) level indicates better speech in noise perception. For example, a score of 0 dB would indicate that the participant can repeat 50% of the words presented when the speech signal and the noise are presented at the same level. A score of 6 dB would indicate that the participant needs the speech signal 6 dB louder than the noise in order to correctly repeat 50% of the words presented. Scores can range from negative db SNR (e.g. -5 dB, which would be a good score and indicate little difficulty in noise) to quite high (e.g. +15 dB, which would be a poorer score and indicate much difficulty in noise) In this case, the scores ranged from +2 to +18 dB.
Day 1 of 1 day study
Study Arms (2)
Naive listeners
EXPERIMENTALParticipants who have never worn a hearing aid before. This group will be tested with both sets of devices, those labeled as "OTC" and those labeled as "Prescriptive"
Experienced users
EXPERIMENTALParticipants who have at least six months experience wearing hearing aids. This group will be tested with both sets of devices, those labeled as "OTC", and those labeled as "Prescriptive"
Interventions
The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "prescriptive" in view of the participant.
The Audeo P is a commercially available hearing aid that is fit by a hearing care professional. The devices will be labeled as "OTC" in view of the participant.
Eligibility Criteria
You may qualify if:
- Adults age 18 or older with bilateral mild to moderate hearing loss
- Experienced users must have at least 6 months Hearing Aid experience
- New users must have no prior hearing aid experience, defined as never owning their own devices
You may not qualify if:
- Self-reported ear related pathology (otorrhea w/in 90 days, dizziness, sudden hearing loss or worsening of hearing w/in 90 days, otalgia)
- Visible deformity of the ear
- Chronic, severe tinnitus
- Unilateral hearing loss
- Cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Sonova US
Aurora, Illinois, 60505, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principle Investigator
- Organization
- Phonak Audiology Research Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Participants will be told they are wearing either a prescriptive hearing aid or an OTC (Over-The-Counter) hearing device based on the labeling of the hearing aids. Both sets of devices will actually be the same. The investigator that is scoring the objective speech in noise test will not know which device the participant is wearing at the time of the test (i.e., the set that is labeled as prescriptive or the set that is labeled as OTC).
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2022
First Posted
March 10, 2022
Study Start
May 26, 2022
Primary Completion
June 16, 2022
Study Completion
June 16, 2022
Last Updated
July 10, 2023
Results First Posted
July 10, 2023
Record last verified: 2023-06