Hearing Aid Signal Processing Comparative Study

NCT ID: NCT04839289

Last Updated: 2023-03-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-08-31

Brief Summary

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Participants will be fit with each of two hearing instruments in an ABA cross-over design. The study will consist of a total of three approximately 10-day home trials with the devices. Participants will be asked to provide qualitative feedback to investigators regarding the performance of and their preference for each hearing instrument.

Detailed Description

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Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Identifying information will be removed from the hearing instruments before fitting the participants. However, participants may be able to research hearing instruments and identify devices based on physical appearance.

Study Groups

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A-B-A

Participants will be fit with hearing instruments A and B in the following order:

Hearing instrument A Hearing instrument B Hearing instrument A

Group Type EXPERIMENTAL

Receiver-in-canal hearing instrument; Manufacturer A

Intervention Type DEVICE

Commercially available receiver-in-canal hearing instrument from manufacturer A

Receiver-in-canal hearing instrument; Manufacturer B

Intervention Type DEVICE

Commercially available receiver-in-canal hearing instrument from manufacturer B

B-A-B

Participants will be fit with hearing instruments A and B in the following order:

Hearing instrument B Hearing instrument A Hearing instrument B

Group Type EXPERIMENTAL

Receiver-in-canal hearing instrument; Manufacturer A

Intervention Type DEVICE

Commercially available receiver-in-canal hearing instrument from manufacturer A

Receiver-in-canal hearing instrument; Manufacturer B

Intervention Type DEVICE

Commercially available receiver-in-canal hearing instrument from manufacturer B

Interventions

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Receiver-in-canal hearing instrument; Manufacturer A

Commercially available receiver-in-canal hearing instrument from manufacturer A

Intervention Type DEVICE

Receiver-in-canal hearing instrument; Manufacturer B

Commercially available receiver-in-canal hearing instrument from manufacturer B

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe sensorineural hearing loss
* Current hearing aid user

Exclusion Criteria

* Lack of willingness to wear study devices for approximately one month
* Inability to travel to study appointments or to complete questionnaires.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SRF-311

Identifier Type: -

Identifier Source: org_study_id

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