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Clinical Trials/NCT03243097
NCT03243097
Completed
Not Applicable

Contralateral Routing of Signal in Unilateral Cochlear Implant Users

University of Miami1 site in 1 country9 target enrollmentAugust 24, 2017
ConditionsHearing Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
University of Miami
Enrollment
9
Locations
1
Primary Endpoint
Speech perception in noise
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 24, 2017
End Date
March 26, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hillary A Snapp

Assistant Professor

University of Miami

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Subjective Benefit(8 weeks)

Study Sites (1)

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