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CROS Application in CI

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University of Miami

Status

Completed

Conditions

Hearing Loss

Treatments

Device: Phase III - No Cros Input
Device: Phase I - Standard Microphone Cros Input
Device: Phase II - Automatic directional microphone Cros Input

Study type

Interventional

Funder types

Other

Identifiers

NCT03243097
20170029

Details and patient eligibility

About

Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear Implants. The majority of bilaterally deafened patients, however, often only receive a unilateral cochlear implant (CI), with resultant limitations related to monaural listening. For unilateral CI users, the deficits inherently associated with monaural listening remain despite the considerable benefits achieved through implantation. Providing bilateral input to monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral routing of signal (CROS) hearing aids, where the signal of interest is routed from the impaired (deaf) ear to the normal cochlea for processing is a promising alternative in unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology provides a less invasive alternative for patients who are unable or unwilling to undergo a second CI surgery and offers an innovative approach to resolving the auditory deficits associated with monaural listening. CROS technology has been used to treat traditional monaural listeners since 1965. When applied to unilateral CI users, this novel approach can overcome a key limitation of current treatment by restoring access to sound from the non-implanted ear and improving speech perception in noise.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Unilateral Advanced Bionics CI recipient
  • ≥ 6 months CI-listening experience and/or better than 50%-word recognition on Consonant-Nucleus-Consonant (CNC) word testing
  • English speaking

Exclusion criteria

  • Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

9 participants in 1 patient group

Study Subjects
Experimental group
Description:
All subjects enrolled in the study are required to complete Phase I before entering Phase II, and Phase II before entering Phase III.
Treatment:
Device: Phase I - Standard Microphone Cros Input
Device: Phase II - Automatic directional microphone Cros Input
Device: Phase III - No Cros Input

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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