Clinical trial NCT05379231: Evaluation of BiCROS Fitting Benefits
Official title: Evaluate the Benefit of a BiCROS Hearing Aid Fitting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Deafness
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Western University, Canada
First posted: 2022-05-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants were wearing the BiCROS fitting during home trial, and tested in-lab with all conditions, randomized and counterbalanced (BiCROS fitting, monaural fitting, unaided).
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Speech Intelligibility in Noise Measured With US Matrix Test (Noise From a Defined Loudspeaker)
timeFrame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting
Secondary outcomes:
measure: Speech Intelligibility in Noise Measured With US Matrix Test (Diffuse Noise)
timeFrame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting
measure: Reports of Subjective Quality of Hearing as Assessed by the SSQ
timeFrame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting
measure: Reports of Subjective Quality of Hearing as Assessed by the Bern Benefit Questionnaires
timeFrame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting
measure: Sound Quality Ratings for Total Impression and Clarity Using Gabriellson et al (1990) Ratings Scales
timeFrame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting
measure: Subjective Preference of Hearing Aid Condition
timeFrame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting
measure: Listening Effort in Noise Using 7 Point Scale (Holmes et. al., 2018)
timeFrame: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting
Other outcomes:
Locations:
city: London
country: Canada
facility: National Centre for Audiology
state: Ontario
city: Mississauga
country: Canada
facility: Sonova Innovation Centre Toronto
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Susan Scollie
role: PRINCIPAL_INVESTIGATOR
References: