Benefits of Assistive Listening Device for Speech Intelligibility

NCT ID: NCT05072470

Last Updated: 2023-02-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2021-12-13

Brief Summary

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Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.

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

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental

Participants with bilateral moderate to severe sensorineural hearing loss

Group Type EXPERIMENTAL

Roger microphone

Intervention Type DEVICE

Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.

Phonak Audeo hearing aid

Intervention Type DEVICE

Commercially available receiver-in-canal hearing aid

Interventions

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Roger microphone

Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.

Intervention Type DEVICE

Phonak Audeo hearing aid

Commercially available receiver-in-canal hearing aid

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
* experienced hearing aid users
* symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)
* good written and spoken English language skills
* healthy outer ear as confirmed by otoscopy

Exclusion Criteria

* contradictions to medical device noted upon otoscopy
* known hypersensitivity or allergy to materials of investigational device or comparator
* inability to produce reliable test results
* known psychological problems
* self reported symptoms of dizziness or vertigo
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hearts for Hearing

OTHER

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hearts for Hearing

Oklahoma City, Oklahoma, 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-70

Identifier Type: -

Identifier Source: org_study_id

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