CROS Application in CI

Hearing Loss Clinical Trial

— CROS  

Official title:

Contralateral Routing of Signal in Unilateral Cochlear Implant Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243097
• Other study ID #: 20170029
• Status: Completed
• Phase: N/A
• Start date: August 24, 2017
• Est. completion date: March 26, 2021

Study information

• Verified date: April 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 26, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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
• 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.
• Phase III - No Cros Input
Subjects will return the research processor and CROS device and wear their own processor for a 2-week period

Locations

Country	Name	City	State
United States	University of Miami Department of Otolaryngology	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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