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Effect of Hearing Aid Labeling on Speech Understanding Measures

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audeo P hearing aid labeled as "Prescriptive"
Audeo P hearing aid labeled as "OTC"
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Sonova US

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Naive listeners

Experienced users

Arm Description

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"

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"

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2022
Last Updated
June 20, 2023
Sponsor
Sonova AG
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1. Study Identification

Unique Protocol Identification Number
NCT05274178
Brief Title
Effect of Hearing Aid Labeling on Speech Understanding Measures
Official Title
Effect of Hearing Aid Labeling on Speech Understanding Measures
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
June 16, 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.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A single group of participants will be involved in this study. All participants will be evaluated with both hearing devices.
Masking
Investigator
Masking Description
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).
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naive listeners
Arm Type
Experimental
Arm Description
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"
Arm Title
Experienced users
Arm Type
Experimental
Arm Description
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"
Intervention Type
Device
Intervention Name(s)
Audeo P hearing aid labeled as "Prescriptive"
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Audeo P hearing aid labeled as "OTC"
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quick Speech in Noise Test (QuickSIN)
Description
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.
Time Frame
Day 1 of 1 day study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Sonova US
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60505
Country
United States

12. IPD Sharing Statement

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Effect of Hearing Aid Labeling on Speech Understanding Measures

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