Effect of Hearing Aid Labeling on Speech Understanding Measures

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Hearing Aid Labeling on Speech Understanding Measures

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Audeo P hearing aid labeled as Prescriptive
* Device: Audeo P hearing aid labeled as OTC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A single group of participants will be involved in this study. All participants will be evaluated with both hearing devices.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naive listeners<br>Participants 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 | Device: Audeo P hearing aid labeled as Prescriptive<br>* 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.<br>Device: Audeo P hearing aid labeled as OTC<br>* 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.<br>|
| Experimental: Experienced users<br>Participants 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 | Device: Audeo P hearing aid labeled as Prescriptive<br>* 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.<br>Device: Audeo P hearing aid labeled as OTC<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |