CROS Application in CI

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Phase I - Standard Microphone Cros Input; Device: Phase II - Automatic directional microphone Cros Input; Device: Phase III - No Cros Input

• Registration Number: NCT03243097
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-08
• Study Start: 2017-08-24
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Speech perception in noise	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 Outcome Measures

Name	Time	Method
Subjective Benefit	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.

Trial Locations

Locations (1)

University of Miami Department of Otolaryngology; 🇺🇸 Miami, Florida, United States