Validation of Novel BTE and SP Hearing Aid Models

NCT ID: NCT04882787

Last Updated: 2024-08-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2021-07-13

Brief Summary

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Participants will wear one set of 2 different BTE hearing aid models based on the gain required by their hearing loss. The hearing aids will be programmed based on a prescriptive approach and participants will be sent out for either one home trial with the less powerful BTEs or for two home trials with the SP (super power) BTEs.

Detailed Description

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During this study each participant will be asked to wear a set of BTE hearing aids home and wear them daily. We will be assessing their evaluation of the BTEs during and after their home field trial. They will be asked to report on their use with different apps/accessories. Subjective performance ratings will be collected.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

2 groups based on hearing aid gain needs; one similar intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BTE hearing aid model

BTE or SP-BTE (super power) hearing aid fitting

Group Type EXPERIMENTAL

BTE hearing aid

Intervention Type DEVICE

Amplification

Interventions

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BTE hearing aid

Amplification

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* hearing aid candidacy (N2-N7 hearing loss)
* healthy outer and middle ears
* ability to complete questionnaires
* willingness to use smartphone
* informed consent documented by a signature
* willingness to wear a binaural BTE fitting
* willingness to use app and accessories
* willingness to adhere to COVID protocols

Exclusion Criteria

* contraindications to the MD in this study: known hypersensitivity or allergy to investigational product/earmold
* limited mobility/not able to attend appointments
* limited ability to describe listening impressions/experiences
* inability to produce a reliable hearing test result
* limited dexterity - to point that participant cannot manage hearing aid insertion/removal
* known psychological disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonova Canada Inc.

INDUSTRY

Sponsor Role collaborator

Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinyu Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Locations

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Unitron Hearing

Kitchener, Ontario, Canada

Site Status

Countries

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Canada

References

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Gabrielsson A, Schenkman BN, Hagerman B. The effects of different frequency responses on sound quality judgments and speech intelligibility. J Speech Hear Res. 1988 Jun;31(2):166-77. doi: 10.1044/jshr.3102.166.

Reference Type BACKGROUND
PMID: 3398490 (View on PubMed)

Valente M, Van Vliet D. The Independent Hearing Aid Fitting Forum (IHAFF) Protocol. Trends Amplif. 1997 Mar;2(1):6-35. doi: 10.1177/108471389700200102. No abstract available.

Reference Type BACKGROUND
PMID: 25425874 (View on PubMed)

Likert, Rensis. A technique for the measurement of attitudes. Archives of Psychology. 1932; 140: 1-55.

Reference Type BACKGROUND

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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378

Identifier Type: -

Identifier Source: org_study_id

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