Evaluation of BiCROS Fitting Benefits
- Conditions
- Unilateral Deafness
- Interventions
- Other: BiCROS fittingOther: Monaural hearing aid fittingOther: Unaided condition
- Registration Number
- NCT05379231
- Lead Sponsor
- Sonova AG
- Brief Summary
23 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- unaidable hearing loss in worse ear (>N6)
- aidable hearing loss (N3 to N5) on the other ear
- fluent English speaker
- aidable hearing loss in both ears
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Speech Intelligibility with CROS device Monaural hearing aid fitting The focus of this study is on Speech Intelligibility (SI), evaluated by the US Matrix Test, which measures a speech recognition threshold (SRT) in dB SNR (signal to noise ratio). Therefore each participant will perform the tests with the experimental rechargeable CROS transmitter (CROS) in different interventions, like comparison to monaural fitting and unaided condition. All participants will perform the same tests. The order of the intervention in the speech test is randomized, but will be performed in the same visit by each participant. Speech Intelligibility with CROS device Unaided condition The focus of this study is on Speech Intelligibility (SI), evaluated by the US Matrix Test, which measures a speech recognition threshold (SRT) in dB SNR (signal to noise ratio). Therefore each participant will perform the tests with the experimental rechargeable CROS transmitter (CROS) in different interventions, like comparison to monaural fitting and unaided condition. All participants will perform the same tests. The order of the intervention in the speech test is randomized, but will be performed in the same visit by each participant. Speech Intelligibility with CROS device BiCROS fitting The focus of this study is on Speech Intelligibility (SI), evaluated by the US Matrix Test, which measures a speech recognition threshold (SRT) in dB SNR (signal to noise ratio). Therefore each participant will perform the tests with the experimental rechargeable CROS transmitter (CROS) in different interventions, like comparison to monaural fitting and unaided condition. All participants will perform the same tests. The order of the intervention in the speech test is randomized, but will be performed in the same visit by each participant.
- Primary Outcome Measures
Name Time Method Speech intelligibility in Noise measured with US Matrix Test (noise from a defined loudspeaker) 7 months Measuring the Signal to Noise Ratio change in decibels for speech from the front loudspeaker and noise from the better ear's side
- Secondary Outcome Measures
Name Time Method Reports of Subjective quality of hearing as assessed by the SSQ 7 months Measured after home trial with the Speech, Spatial and Qualities of Hearing Scale (Gatehouse, 2004)
Listening effort in noise using 7 point scale (Johnson et al, 2015) 7 months Measuring listening effort for speech in multi-talker babble presented via loudspeaker
Speech intelligibility in Noise measured with US Matrix Test (diffuse noise) 7 months Measuring the Signal to Noise Ratio change in decibels for speech from the front loudspeaker in surrounding noise
Subjective preference of hearing aid condition 7 months 3 alternative forced choice (A, B, no preference or ABX) paradigm with three repetitions for speech in noise presented via loudsepakers
Reports of Subjective quality of hearing as assessed by the Bern Benefit Questionnaires 7 months Measured after home trial with the Bern Benefit in Single-Sided Deafness Questionnaire (Komps et al, 2011)
Sound quality ratings for Total Impression and Clarity using Gabriellson et al (1990) Ratings Scales 7 months Ratings of speech in quiet and in noise presented via loudspeakers
Trial Locations
- Locations (2)
Sonova Innovation Centre Toronto
🇨🇦Mississauga, Ontario, Canada
National Centre for Audiology
🇨🇦London, Ontario, Canada