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Completed

NCT Number: NCT04882787

Validation of Novel BTE and SP Hearing Aid Models

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unitron Hearing

Kitchener, Ontario, N2E 1Y6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BTE hearing aid

Device

Amplification

Primary outcomes

  1. Number of Participants With 'Total Impression' Sound Quality as 'Good'

    Time frame: final appointment (end of 3 weeks home trial for BTE model, end of 7 weeks home trial for SP-BTE model)

    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.

Secondary outcomes

  1. Number and Percentage of Participants Reporting No Reboots

    Time frame: 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)

    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)'.

  2. Number of Participants Reporting Perceived Differences With Both of the App Boost Controls

    Time frame: initial appointment (day of fitting of hearing aids)

    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?'

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

    Time frame: initial appointment (day of fitting of hearing aids)

    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?'

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • Sonova Canada Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 12, 2021
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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