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Completed

NCT Number: NCT05379231

Evaluation of BiCROS Fitting Benefits

22 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a CROS device. Following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in noise, ratings of listening effort, and ratings of preference.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Centre for Audiology, London, Ontario, Canada

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About this study

Unilateral Hearing Loss (UHL) can be defined as any degree of permanent hearing loss on one ear with normal hearing in the opposite ear. Unilateral hearing loss can be debilitating associated with audiological, psychosocial and educational challenges. Audiological challenges include the reduced ability to localize sounds, reduced awareness on the unaidable side and difficulties hearing in noise or at a distance.

One solution for unaidable UHL is Contralateral Routing of Signals (CROS) and Bilateral Contralateral routing of signals (BiCROS) using a so-called CROS transmitter together with a hearing aid.

The rationale for this clinical investigation is to collect clinical data with a rechargeable CROS transmitter to evaluate the benefits of a BiCROS fitting compared to the alternative treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening situations.

Hearing tests, ear impressions and hearing aid fitting visits are mainly conducted at the National Centre for Audiology in London, Ontario. Those visits are available at the Sonova Innovation Centre Toronto in Mississauga, Ontario, upon request. Outcome measurements are only conducted at the National Centre for Audiology in London, Ontario.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • unaidable hearing loss in worse ear (>N6)
  • aidable hearing loss (N3 to N5) on the other ear
  • fluent English speaker

Exclusion criteria

  • aidable hearing loss in both ears

Treatment and study plan

Hearing Aid fitting

Device

A participant will wear a hearing aid with and without a CROS device on the unaidable ear.

Primary outcomes

  1. Speech Intelligibility in Noise Measured With US Matrix Test (Noise From a Defined Loudspeaker)

    Time frame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

    Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker and noise from the better ear's side with the US matrix Test. Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio).

    The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A)).

    The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 65 dB (A).

Secondary outcomes

  1. Speech Intelligibility in Noise Measured With US Matrix Test (Diffuse Noise)

    Time frame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

    Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker in surrounding noise with the US Matrix Test. Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio).

    The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A).

    The noise will be presented from a circle of 8 surrounding speakers from 45° to 315° at a level of 65 dB (A) with the participant seated in the centre of the circle.

  2. Reports of Subjective Quality of Hearing as Assessed by the SSQ

    Time frame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

    Measured after home trial with the Speech, Spatial and Qualities of Hearing Scale-Benefit (Gatehouse, 2004). The scale ranges from -5 to 5, where negative values indicate that the condition under test is worse than the comparator, 0 indicates no change, and positive values indicate a benefit of the condition under test compared to the comparator.

  3. Reports of Subjective Quality of Hearing as Assessed by the Bern Benefit Questionnaires

    Time frame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

    Measured after home trial with the Bern Benefit in Single-Sided Deafness Questionnaire (Komps et al, 2011). The scale ranges from -5 to 5, where negative values indicate that the condition under test is better wihtout the hearing aid, 0 indicates no change, and positive values indicate a benefit with the hearing aid.

  4. Sound Quality Ratings for Total Impression and Clarity Using Gabriellson et al (1990) Ratings Scales

    Time frame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

    Ratings of speech in noise presented via loudspeakers using Gabriellson et al (1990) Ratings Scales. Scales include Clarity and Total Impression, and range from 1 to 10. The higher the rating, the better the Clarity and Total Impression.

  5. Subjective Preference of Hearing Aid Condition

    Time frame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

    3 alternative forced choice (A, B, no preference or ABX) paradigm with three repetitions for speech in noise presented via loudsepakers

  6. Listening Effort in Noise Using 7 Point Scale (Holmes et. al., 2018)

    Time frame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting

    Measuring listening effort for speech in multi-talker babble presented via loudspeaker. The scale ranges from 1 to 7, and a higher rating indicates less listening effort.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • Western University, Canada

Registry information

Official study title

Evaluate the Benefit of a BiCROS Hearing Aid Fitting

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 18, 2022
Registry last updated
Jun 11, 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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