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

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Sonova

Status

Terminated

Conditions

Hearing Loss

Treatments

Other: BiCROS fitting
Other: CROS baseline
Other: Unaided condition
Other: Monaural fitting

Study type

Interventional

Funder types

Industry

Identifiers

NCT05106413
SRF-377

Details and patient eligibility

About

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.

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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 1 patient group

Speech Intelligibility with CROS device
Experimental group
Description:
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.
Treatment:
Other: Unaided condition
Other: Monaural fitting
Other: CROS baseline
Other: BiCROS fitting

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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