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Validation of Novel BTE and SP Hearing Aid Models

Primary Purpose

Hearing Loss

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

BTE hearing aid

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Unitron Hearing

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BTE hearing aid model

Arm Description

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

Outcomes

Primary Outcome Measures

Sound Quality

Subjective evaluation of sound quality using Sound Quality Ratings from Gabrielsson et al 1988 (The effects of different frequency responses on sound quality judgments and speech intelligibility. JSHR. Vol.31)

Secondary Outcome Measures

System Stability

Reports of system stability with accessories and Subjective evaluation of sound quality using Sound Quality Ratings from Gabrielsson et al 1988 (The effects of different frequency responses on sound quality judgments and speech intelligibility. JSHR. Vol.31)

Usability

Reports of app usability/sound quality using Sound Quality Ratings from Gabrielsson et al 1988 (The effects of different frequency responses on sound quality judgments and speech intelligibility. JSHR. Vol.31)

Full Information

NCT ID

NCT04882787

First Posted

May 4, 2021

Last Updated

September 14, 2021

Sponsor

Sonova AG

Collaborators

Sonova Canada Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04882787

Brief Title

Validation of Novel BTE and SP Hearing Aid Models

Official Title

Validation of 2 Novel BTE Hearing Aid Models Varying With Respect to Regular-power or Super-power Gain Specifications

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

May 14, 2021 (Actual)

Primary Completion Date

July 13, 2021 (Actual)

Study Completion Date

July 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sonova AG

Collaborators

Sonova Canada Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BTE hearing aid model

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

BTE hearing aid

Intervention Description

Amplification

Primary Outcome Measure Information:

Title

Sound Quality

Description

Time Frame

3-7 weeks

Secondary Outcome Measure Information:

Title

System Stability

Description

Time Frame

3-7 weeks

Title

Usability

Description

Time Frame

3-7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinyu Qian, PhD

Organizational Affiliation

Sonova AG

Official's Role

Principal Investigator

Facility Information:

Facility Name

Unitron Hearing

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2E 1Y6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Validation of Novel BTE and SP Hearing Aid Models

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