Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss

NCT ID: NCT06746038

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-03-15

Brief Summary

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This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.

Detailed Description

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This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss. Participants will be experienced hearing aid users who have previously worn or currently wear extended wear hearing devices. The primary objective will be to assess subjective listening effort, compared to unaided.

Conditions

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Sensorineural Hearing Loss

Keywords

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extended wear hearing aid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single group of participants will be fit with the extended wear hearing devices and will be tested in both the aided and unaided conditions in various tasks. Conditions will be counterbalanced and all participants will experience the same conditions. Conditions will include unaided, aided with pre-calculation A, and aided with pre-calculation B.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group

Participants who are fit with study Lyric devices and tested on speech intelligibility and effort using two different fitting algorithms

Group Type EXPERIMENTAL

Extended Wear Hearing Aid

Intervention Type DEVICE

Extended wear hearing aid means that the device is worn 24 hours per day, 7 days a week for months at a time. However, this study will only fit devices on participants for one testing session lasting 2 hours.

Interventions

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Extended Wear Hearing Aid

Extended wear hearing aid means that the device is worn 24 hours per day, 7 days a week for months at a time. However, this study will only fit devices on participants for one testing session lasting 2 hours.

Intervention Type DEVICE

Other Intervention Names

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Lyric4

Eligibility Criteria

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Inclusion Criteria

* Meets requirements outlined on Lyric Candidacy Form
* Current Lyric hearing instrument user
* 18 years of age or older at time of enrollment in the study
* Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear
* Good understanding (read/write/speak) of the English language
* Willingness to comply with all study requirements

Exclusion Criteria

* Does not meet requirements outlined on Lyric Candidacy Form (see Chapter 9 of the TMF/ISF for SRF-469)
* Difficulty understanding/reading instructions when corrected for vision loss
* Impairments that would restrict participation in any of the evaluations
* Ear health conditions present at baseline that prevent immediate device replacement
* Conditions that would indicate the need for medical referral prior to hearing aid fitting, according to clinic's standard protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Woodlands Hearing Center

UNKNOWN

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Woodlands Hearing Center

Shenandoah, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Study Manager

Role: CONTACT

Phone: 630-821-5000

Email: [email protected]

Other Identifiers

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SRF-469

Identifier Type: -

Identifier Source: org_study_id