CROS Application in CI (CROS)

Contralateral Routing of Signal in Unilateral Cochlear Implant Users

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 Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Phase I - Standard Microphone Cros Input; Device: Phase II - Automatic directional microphone Cros Input; Device: Phase III - No Cros Input

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Department of Otolaryngology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Phase I - Standard Microphone Cros Input; Subject will be fit with the research processor plus CROS microphone and wear for a 4 week period; 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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Hillary Snapp, AuD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2017
• Primary Completion (Actual): March 12, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: June 7, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 20170029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No