Evaluation of Investigational Hearing Instrument Features

NCT ID: NCT06710236

Last Updated: 2024-11-29

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2025-03-31

Brief Summary

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The goal of this clinical trial is to learn how hearing instruments perform in varying environmental settings in adults with hearing loss. The main questions it aims to answer are:

How do varying versions of hearing instrument features perform based on exposure to different environments? What is the hearing instrument user preference between varying versions of hearing instrument features?

Participants will be fit with hearing instruments in the lab, and asked to wear them for the duration of the study period in their home environment. Participants will be asked to answer questionnaires throughout the study period.

Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants all receive the same intervention/hearing aid, but will be blinded as to which program they are being tested with.

Study Groups

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Hearing Aid Users

Participants will wear hearing instruments for the duration of the study period. They will be asked to complete questionnaires about their environment and experience.

Group Type EXPERIMENTAL

Hearing instrument

Intervention Type DEVICE

Conventional, daily wear hearing instruments will be used in this study.

Interventions

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Hearing instrument

Conventional, daily wear hearing instruments will be used in this study.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult, age 18 - 95 years
* N4 hearing loss
* Experienced hearing aid user
* English fluency
* Cognitively able to complete complex listening tasks

Exclusion Criteria

* Normal hearing, or hearing loss outside the specified range
* No hearing aid experience
* Unable to speak, read, or write English fluently
* Cognitive impairment
* Any other condition or situation that impacts eligibility to participate in or complete study tasks, at the discretion of the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phonak Audiology Research Center

Aurora, Illinois, United States

Site Status

Countries

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United States

Central Contacts

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Research Audiologist

Role: CONTACT

Phone: 800-679-4871

Email: [email protected]

Facility Contacts

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Study Coordinator

Role: primary

Other Identifiers

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SRF-26463

Identifier Type: -

Identifier Source: org_study_id