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Completed

NCT Number: NCT05197803

Clinical Study of Released Unitron RIC and BTE Hearing Aid Models

The present study will confirm the clinical benefit of 2 different released hearing aid models for speech understanding (in noise). Participants with mild to severe hearing impairment will be fit binaurally with Unitron hearing aids and will perform a standardized speech discrimination test in noise with and without hearing aids.

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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–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unitron Hearing

Kitchener, Ontario, N2E 1Y6, Canada

About this study

Each participant will be asked to wear a set of BTE and RIC hearing aids and complete the Hearing in Noise Test (HINT) aided and unaided. The investigators will be assessing their speech intelligibility in noise for each condition during the same appointment to determine the SNR50 (the Signal-to-Noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults (18+ years) with hearing impairment (N2 - N6 hearing loss).
  • Healthy outer ear.
  • Symmetrical hearing loss.
  • Ability to answer questions and repeat sentences.
  • Informed consent as documented by signature.
  • Willingness to wear different style of hearing aids.
  • Willingness to wear a binaural fitting.
  • Willingness to wear closed domes.
  • Willingness to adhere to COVID protocols including correct mask use, completing screening for each visit

Exclusion criteria

  • Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational product).
  • Limited mobility/not able to come to scheduled visits.
  • Inability to produce reliable hearing test result.
  • Visible congenital or traumatic deformity of the outer ear.
  • History of active drainage from the ear in the previous 90 days.
  • Abnormal appearance of the eardrum and ear canal.
  • Acute or chronic dizziness.
  • Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz.
  • Known psychological problems.

Treatment and study plan

Hearing Aid

Device

Participants will complete testing aided and unaided. The hearing aids have been fit to compensate for their hearing loss.

Primary outcomes

  1. Speech Intelligibility Test in Noise

    Time frame: 2 hours appointment

    Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • Sonova Canada Inc.

Registry information

Official study title

Clinical Study of Released Unitron RIC (Receiver in Canal) and BTE (Behind the Ear) Hearing Aid Models

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
May 7, 2025

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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