Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants

Telemedicine Clinical Trial

— TEL  

Official title:

Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644343
• Other study ID #: CAM 5650
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 17, 2017

Study information

• Verified date: November 2020
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.

Description:

Cochlear implant recipients will undergo remapping at a location remote from their audiologist via telehealth. Audiologists will use an internet meeting platform to remotely log into the subject's computer and control the programming software. Remote programming sessions will be completed both with and without the assistance of a trained facilitator, and speech understanding will be tested in between mapping sessions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 17, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Individuals aged greater than 12 years that are native English speakers and are capable of completing the study evaluation as deemed by their primary audiologist

• Unilateral or bilateral cochlear implant recipients of a CI24RE, CI422 or CI500 series implant who are in possession of a backup sound processor

• A minimum of 12 months' experience with a CP800 or CP900 series sound processor, and current MAP programmed within 12 months prior to Visit 1

• Willingness to participate in and to comply with all requirements of the protocol

• Able to demonstrate protocol competence as confirmed by primary audiologist

Exclusion Criteria:

• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of remote service delivery

• Unwillingness or inability of the candidate to comply with all investigational requirements

• Additional handicaps that would prevent or restrict participation in the audiological evaluations

• Inability to demonstrate basic technological skills for simple computer-based tasks and device connecting after training by primary audiologist

Related Conditions & MeSH terms

• Telemedicine

Intervention

Device:
• Custom Sound
Custom Sound is the programming software used to program Nucleus cochlear implants.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Rocky Mountain Ear Center	Englewood	Colorado
United States	The Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

United States, 

References & Publications (4)

Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. — View Citation

McElveen JT Jr, Blackburn EL, Green JD Jr, McLear PW, Thimsen DJ, Wilson BS. Remote programming of cochlear implants: a telecommunications model. Otol Neurotol. 2010 Sep;31(7):1035-40. doi: 10.1097/MAO.0b013e3181d35d87. — View Citation

PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. — View Citation

Wesarg T, Wasowski A, Skarzynski H, Ramos A, Falcon Gonzalez JC, Kyriafinis G, Junge F, Novakovich A, Mauch H, Laszig R. Remote fitting in Nucleus cochlear implant recipients. Acta Otolaryngol. 2010 Dec;130(12):1379-88. doi: 10.3109/00016489.2010.492480. Epub 2010 Jun 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech Perception on Monosyllabic Word Test, CNC Words	Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test measured by percentage of words correct to examine their speech perception abilities after each remote programming session.	2-4 weeks post remote programming session