CROS Application in CI

NCT ID: NCT03243097

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-24
• Study Completion Date: 2021-03-26

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Study Subjects

All subjects enrolled in the study are required to complete Phase I before entering Phase II, and Phase II before entering Phase III.

Group Type: EXPERIMENTAL

Phase I - Standard Microphone Cros Input

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

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

Interventions

Phase I - Standard Microphone Cros Input

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

Intervention Type: DEVICE

Phase II - Automatic directional microphone Cros Input

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.

Intervention Type: DEVICE

Phase III - No Cros Input

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Hillary A Snapp

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hillary Snapp, AuD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Department of Otolaryngology

Miami, Florida, United States

Countries

United States

Other Identifiers

20170029

Identifier Type: -

Identifier Source: org_study_id