NCT05106413

Evaluation of the Clinical Benefit of a Transmitter for Contralateral Routing of Signals (CROS)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Sonova AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the clinical benefit of a transmitter for contralateral routing of signals. The benefit will be evaluated in noisy environments regarding speech intelligibility when the CROS system is adjusted to different microphone settings. Additionally, data regarding overall system stability, crash reboot rate, sound quality and connectivity will be obtained over a period of time to validate the CROS system in combination with smartphone and accessories. This study is a confirmatory study.

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
OTHER	BiCROS fitting	Each participant will be fitted with the experimental CROS device on the poorer, unaidable ear and with a compatible hearing device on the other ear.
OTHER	Monaural fitting	Each participant will be fitted with a hearing aid on the better hearing ear and no device on the poorer, unaidable ear. Monaural hearing aid fitting acts as control intervention.
OTHER	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.
OTHER	CROS baseline	Each participant will be fitted with the experimental CROS device on the poorer, unaidable ear and with a compatible device on the other ear. The difference to the BiCROS condition is the setup of the microphones in the CROS device and the compatible hearing device. This test condition is only tested for speech intelligibility in diffuse noise and acts as control intervention.

Timeline

• Start date: 2021-10-26
• Primary completion: 2022-03-14
• Completion: 2022-03-14
• First posted: 2021-11-03
• Last updated: 2022-04-15

Locations

1 site across 1 country: Switzerland