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

NCT05106413 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-04-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Sonova AG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2022-03-14
Completion
2022-03-14

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05106413 on ClinicalTrials.gov