Validation of Novel BTE and SP Hearing Aid Models

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: BTE hearing aid

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kitchener, Ontario, Canada, N2E 1Y6
      • Unitron Hearing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BTE hearing aid model; BTE or SP-BTE (super power) hearing aid fitting	Device: BTE hearing aid; Amplification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 'Total Impression' Sound Quality as 'Good'	Participants with 'good' response of 7 or higher on 'Total Impression' scale; Gabrielsson citation/article includes seven perceptual scales and a scale for 'Total Impression' which is described as 'an overall judgment of how good you think the reproduction is'. Possible scores from 0 to 10 with descriptors provided: 0 (min), 1 (very bad), 3 (rather bad), 5 (midway), 7 (rather good), 9 (very good), 10 (max) A higher score reflects a better outcome.	final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Participants Reporting No Reboots	Participants to report perceived unwanted reboots of the hearing aids as an indicator of system stability (with use of 2.4 GHz connectivity including accessories and smartphones). Possible responses for perceived reboots (i.e., instances when the amplified sound dropped out and then returned) are: 'No (0) reboots perceived' or 'Reboots perceived (1 or more)'.	at any time during home trial, reported at or by final appointment(end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)
Number of Participants Reporting Perceived Differences With Both of the App Boost Controls	Number of SP-BTE participants reporting perceived differences from adjustment of the app's Boost controls. Stimuli were presented in a sound room to check the Clarity & Comfort Boosts in the app (available in Automatic Program). To comment on the effect of the Boosts, participants listened to simulated acoustic scenarios, initially under default settings (i.e., with no Boost), then with each Boost (Comfort then Clarity) activated separately (by pressing a button on a screen in the app). Yes/No answer to confirm a perceived difference -- 'Did you notice a difference?'	initial appointment (day of fitting of hearing aids)
Number of Participants Reporting Perceived Differences With Both of the App Slider Controls	Number of SP-BTE participants reporting perceived differences from adjustment of two of the app's Slider controls. Stimuli were presented in a sound room to check the Enhance Speech and Reduce Noise sliders in the app (available in Manual Program). To comment on the effect of the Sliders, participants were asked to adjust the Enhance Speech and Reduce Noise Sliders (separately) to the Maximum and Minimum settings (by sliding the setting indicator across the available range). Yes/No answer to confirm a perceived difference -- 'Did you notice a difference?'	initial appointment (day of fitting of hearing aids)

Collaborators and Investigators

• Sponsor: Sonova AG
• Collaborators: Sonova Canada Inc.
• Investigators: Principal Investigator: Jinyu Qian, PhD, Sonova AG

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No