CROS Application in CI

NCT03243097 | Completed FDA Device

• 1 other identifier: 20170029
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Subjective Benefit

  8 weeks

Study Arms (1)

Study Subjects

EXPERIMENTAL

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

Device: Phase I - Standard Microphone Cros Input; Device: Phase II - Automatic directional microphone Cros Input; Device: Phase III - No Cros Input

Interventions

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

Study Subjects

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.

Study Subjects

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

Study Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Department of Otolaryngology

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hillary Snapp, AuD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: August 8, 2017
• Study Start: August 24, 2017
• Primary Completion: March 12, 2021
• Study Completion: March 26, 2021
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)