Validation of Novel BTE and SP Hearing Aid Models

NCT04882787 | Completed Results

• 1 other identifier: 378
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number and Percentage of Participants Reporting No Reboots

  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

  initial appointment (day of fitting of hearing aids)

• Number of Participants Reporting Perceived Differences With Both of the App Slider Controls

  initial appointment (day of fitting of hearing aids)

Study Arms (1)

BTE hearing aid model

EXPERIMENTAL

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

Device: BTE hearing aid

Interventions

BTE hearing aid DEVICE

Amplification

BTE hearing aid model

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonova AG: lead
• Sonova Canada Inc.: collaborator

Study Sites (1)

Unitron Hearing

Kitchener, Ontario, N2E 1Y6, Canada

Location

Related Publications (3)

• 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.

  PMID: 3398490 BACKGROUND

• 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.

  PMID: 25425874 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jinyu Qian, Director Innovation Centre Toronto
• Organization: Sonova

jinyu.qian@sonova.com

905-677-1167

Study Officials

• Jinyu Qian, PhD

  Sonova AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 12, 2021
• Study Start: May 14, 2021
• Primary Completion: July 13, 2021
• Study Completion: July 13, 2021
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)