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OpenTrials
Completed

NCT Number: NCT03243097

CROS Application in CI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Department of Otolaryngology

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phase I - Standard Microphone Cros Input

Device

Subject will be fit with the research processor plus CROS microphone and wear for a 4 week period

Phase II - Automatic directional microphone Cros Input

Device

Automatic directional microphone technology will be activated in the research processor. Subjects will wear the CI+CROS configuration with directionality activated exclusively for 4-weeks.

Phase III - No Cros Input

Device

Subjects will return the research processor and CROS device and wear their own processor for a 2-week period

Primary outcomes

  1. Speech perception in noise

    Time frame: 8 weeks

    Speech perception in noise will be evaluated with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.

Secondary outcomes

  1. Subjective Benefit

    Time frame: 8 weeks

    Benefit of wireless CROS technology with the cochlear implant will be assessed using a customized questionnaire with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Contralateral Routing of Signal in Unilateral Cochlear Implant Users

Acronym: CROS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 8, 2017
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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