Evaluation of Hearing Aid Benefit

NCT ID: NCT05198713

Last Updated: 2023-06-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2022-03-04

Brief Summary

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The present study will investigate the benefit of hearing aids for speech intelligibility (in both quiet and noisy environments) compared to the unaided condition. Participants will include adults with moderate to moderately severe hearing impairment. The participants will complete laboratory-based speech intelligibility assessments with binaural hearing aids and without hearing aids.

Detailed Description

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Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

All participants will be fit with the study hearing aid and under go the same testing conditions.

Group Type EXPERIMENTAL

New hearing aid

Intervention Type DEVICE

Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.

Interventions

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New hearing aid

Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Moderate to moderately severe sensorineural hearing loss
* Willingness to wear custom hearing instruments during the study.
* Age-normal cognition
* Ability to attend on-site study visits.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 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

Principal Investigators

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Kevin Seitz-Paquette, AuD

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Locations

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Phonak Audiology Research Center

Aurora, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SRF-487

Identifier Type: -

Identifier Source: org_study_id

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