Validation of Novel BTE and SP Hearing Aid Models

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882787
• Other study ID #: 378
• Status: Completed
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: July 13, 2021

Study information

• Verified date: September 2021
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 13, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• BTE hearing aid
Amplification

Locations

Country	Name	City	State
Canada	Unitron Hearing	Kitchener	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Sonova Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3-7 weeks
Secondary	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)	3-7 weeks
Secondary	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)	3-7 weeks