Evaluation of BiCROS Fitting Benefits

Unilateral Deafness Clinical Trial

Official title:

Evaluate the Benefit of a BiCROS Hearing Aid Fitting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05379231
• Other study ID #: 461
• Status: Completed
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: March 21, 2023

Study information

• Verified date: March 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 21, 2023
• Est. primary completion date: March 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss, Unilateral
• Unilateral Deafness

Intervention

Other:
• BiCROS fitting
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear.
• Monaural hearing aid fitting
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. Monaural hearing aid fitting acts as control intervention.
• Unaided condition
No treatment, i.e. the participants are not fitted with a CROS device and/ or hearing aid. Unaided condition acts as control intervention.

Locations

Country	Name	City	State
Canada	National Centre for Audiology	London	Ontario
Canada	Sonova Innovation Centre Toronto	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech intelligibility in Noise measured with US Matrix Test (noise from a defined loudspeaker)	Measuring the Signal to Noise Ratio change in decibels for speech from the front loudspeaker and noise from the better ear's side	7 months
Secondary	Speech intelligibility in Noise measured with US Matrix Test (diffuse noise)	Measuring the Signal to Noise Ratio change in decibels for speech from the front loudspeaker in surrounding noise	7 months
Secondary	Reports of Subjective quality of hearing as assessed by the SSQ	Measured after home trial with the Speech, Spatial and Qualities of Hearing Scale (Gatehouse, 2004)	7 months
Secondary	Reports of Subjective quality of hearing as assessed by the Bern Benefit Questionnaires	Measured after home trial with the Bern Benefit in Single-Sided Deafness Questionnaire (Komps et al, 2011)	7 months
Secondary	Sound quality ratings for Total Impression and Clarity using Gabriellson et al (1990) Ratings Scales	Ratings of speech in quiet and in noise presented via loudspeakers	7 months
Secondary	Subjective preference of hearing aid condition	3 alternative forced choice (A, B, no preference or ABX) paradigm with three repetitions for speech in noise presented via loudsepakers	7 months
Secondary	Listening effort in noise using 7 point scale (Johnson et al, 2015)	Measuring listening effort for speech in multi-talker babble presented via loudspeaker	7 months