Evaluation of BiCROS Fitting Benefits

Sonova

Status: Completed

Conditions: Unilateral Deafness

Treatments: Device: Hearing aid fitting

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05379231

461

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 5 patient groups

BiCROS fitting with beamformer

Experimental group

Description:

Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer (directional microphone) will be enabled during this measurement. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.

Treatment:

Device: Hearing aid fitting

BiCROS fitting omni

Experimental group

Description:

Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.

Treatment:

Device: Hearing aid fitting

Monaural hearing aid fitting with beamformer

Active Comparator group

Description:

Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer (directional microphone) will be enabled during the measurement. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.

Treatment:

Device: Hearing aid fitting

Monaural hearing aid fitting omni

Active Comparator group

Description:

Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.

Treatment:

Device: Hearing aid fitting

Unaided condition

No Intervention group

Description:

No intervention, the participants are not fitted with a CROS device and/or hearing aid.