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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-26

Study Completion Date

2022-03-14

Brief Summary

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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.

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Detailed Description

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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

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Speech Intelligibility with CROS device

The focus of this study is on Speech Intelligibility (SI), evaluated by the Oldenburg Sentence test (OLSA), which measures a speech recognition threshold (SRT) in dB SNR (signal to noise ratio).

Therefore each participant will perform the tests with the experimental rechargeable CROS transmitter (CROS) in different interventions, like comparison to monaural fitting and unaided condition.

All participants will perform the same tests. The order of the intervention in the speech test is randomized, but will be performed in the same visit by each participant.

Group Type EXPERIMENTAL

BiCROS fitting

Intervention Type OTHER

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.

Monaural fitting

Intervention Type OTHER

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.

Unaided condition

Intervention Type OTHER

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

Unaided condition acts as control intervention.

CROS baseline

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* hearing impaired adults, with \& w/o hearing aids (experiences)
* good written and spoken (Swiss) German language skills
* ability to fill in a questionnaire conscientiously
* informed consent as documented by signature
* asymmetric hearing loss: one unaidable ear (min. N6 hearing loss) / the other ear with N3 or N4 hearing loss
* availability of Smartphone
* availability of TV or Tablet
* ability to operate and handle the investigational device
* ability to describe listening impressions/experiences and the use of the hearing aid
* Ability to produce a reliable hearing test result

Exclusion Criteria

* Contraindications to the medical device:
* aidable hearing loss on the intended CROS side
* acute tinnitus (in either one ear and occurrence less than three months)
* anatomical deformity of the CROS ear (e.g. absence of the auricle)
* Known hypersensitivity or allergy to materials of the investigational device
* any auricle deformities, that prevents secure placement of the (test) devices
* no willingness to test the investigational device system
* no willingness to test the investigational device system for at least 8h a day
* Hint for psychological problems from investigators point of view
* reported fluctuating hearing that could influence the test result
* reported symptoms of vertigo and dizziness by participants

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No