CROS Application in CI

University of Miami9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Hearing Loss

Phase I - Standard Microphone Cros InputDEVICE

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

Phase II - Automatic directional microphone Cros InputDEVICE

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 InputDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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.

Time frame: 8 weeks

Secondary Outcomes

Subjective Benefit

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.