Benefit of Assistive Listening Device for Lateralization

NCT ID: NCT05072457

Last Updated: 2023-06-15

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

2022-07-02

Brief Summary

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Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.

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

OTHER

Blinding Strategy

NONE

Study Groups

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Experimental

All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.

Group Type EXPERIMENTAL

Roger On microphone

Intervention Type DEVICE

Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids

Roger Select microphone

Intervention Type DEVICE

Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids

Interventions

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Roger On microphone

Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids

Intervention Type DEVICE

Roger Select microphone

Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Experienced hearing aid users, age 18 or older
* Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
* Good understanding of the English language
* Health outer ear as confirmed by otoscopy
* Informed consent as documented by signature

Exclusion Criteria

* Contraindications to the medical device noted upon otoscopy
* Known hypersensitivity or allergies to materials of the investigations device or comparator
* Inability to produce reliable test results
* Known psychological problems
* Self reported symptoms of vertigo or dizziness
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 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-387

Identifier Type: -

Identifier Source: org_study_id

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