MED-EL Remote Care Multi-Center Feasibility Study

NCT05973669 | Enrolling By Invitation FDA Device

• 1 other identifier: US2302 MED-EL Remote Care
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 5

Brief Summary

MED-EL Remote Care is a way for MED-EL cochlear implant users to check their hearing and cochlear implant device from any location, without the need for a scheduled, in-person appointment with their audiologist. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.

Conditions

Hearing Loss, Sensorineural; Cochlear Implant; Cochlear Implant Recipients; Hearing Disorders; Cochlear Implants

Keywords

cochlear implants; telehealth; remote care

Outcome Measures

Primary Outcomes (1)

• Remote Care Completion

  Number and proportion of fully completed Remote Care visits.

  Up to 6 months post-training

Secondary Outcomes (6)

• Patient time savings

  Up to 6 months post-training

• Patient cost estimates

  Up to 6 months post-training

• Clinician time savings

  Up to 6 months post-training

• Patient Feedback Survey

  Up to 6 months post-training

• Clinician Feedback Survey

  Mid-enrollment to enrollment completion

Study Arms (1)

Remote cochlear implant support

EXPERIMENTAL

Participants will use MED-EL Remote Care to test their hearing and device functionality. Participants and clinicians will complete user feedback surveys regarding their experience and time/cost-savings.

Device: MED-EL Remote Care

Interventions

MED-EL Remote Care DEVICE

Remote cochlear implant support

Remote cochlear implant support

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Implanted with at least one MED-EL cochlear implant
• ≥ 2 weeks since activation of the cochlear implant
• Availability of existing aided Pediatric/AZ Bio (quiet and/or noise) and CNC word scores, or the ability to complete these at baseline
• Utilizing a compatible audio processor in the SONNET or RONDO product lines
• Ability to complete app-based hearing assessments
• Commitment to comply with all study procedures for the duration of the study
• Access to the internet via a smartphone that meets the following requirements:
• Android or iOS operating systems
• A smartphone supporting Bluetooth® 4.2 or higher
• A minimum of 200 MB free storage space

You may not qualify if:

• Inability or unwillingness to perform the requirements of the clinical investigation
• Unrealistic expectations regarding the possible benefits, risks, and limitations of remote cochlear implant care
• Inability of the subject or caregiver to demonstrate basic skills for operating a smartphone, computer, or app-based tasks after training by the investigator

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (5)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (9)

• Maruthurkkara S, Case S, Rottier R. Evaluation of Remote Check: A Clinical Tool for Asynchronous Monitoring and Triage of Cochlear Implant Recipients. Ear Hear. 2022 Mar/Apr;43(2):495-506. doi: 10.1097/AUD.0000000000001106.

  PMID: 34320523 BACKGROUND

• Takano K, Kaizaki A, Kimura A, Nomura K, Yamazaki N, Shintani T, Himi T. Telefitting of Nucleus Cochlear Implants: A Feasibility Study. Am J Audiol. 2021 Mar 10;30(1):16-21. doi: 10.1044/2020_AJA-20-00041. Epub 2021 Feb 8.

  PMID: 33555935 BACKGROUND

• Slager HK, Jensen J, Kozlowski K, Teagle H, Park LR, Biever A, Mears M. Remote Programming of Cochlear Implants. Otol Neurotol. 2019 Mar;40(3):e260-e266. doi: 10.1097/MAO.0000000000002119.

  PMID: 30741905 BACKGROUND

• Cullington H, Kitterick P, Weal M, Margol-Gromada M. Feasibility of personalised remote long-term follow-up of people with cochlear implants: a randomised controlled trial. BMJ Open. 2018 Apr 20;8(4):e019640. doi: 10.1136/bmjopen-2017-019640.

  PMID: 29678970 BACKGROUND

• Schepers K, Steinhoff HJ, Ebenhoch H, Bock K, Bauer K, Rupprecht L, Moltner A, Morettini S, Hagen R. Remote programming of cochlear implants in users of all ages. Acta Otolaryngol. 2019 Mar;139(3):251-257. doi: 10.1080/00016489.2018.1554264.

  PMID: 31056039 BACKGROUND

• Hughes ML, Sevier JD, Choi S. Techniques for Remotely Programming Children With Cochlear Implants Using Pediatric Audiological Methods via Telepractice. Am J Audiol. 2018 Nov 19;27(3S):385-390. doi: 10.1044/2018_AJA-IMIA3-18-0002.

  PMID: 30452743 BACKGROUND

• Eikelboom RH, Jayakody DM, Swanepoel DW, Chang S, Atlas MD. Validation of remote mapping of cochlear implants. J Telemed Telecare. 2014 Jun;20(4):171-177. doi: 10.1177/1357633X14529234. Epub 2014 Mar 27.

  PMID: 24675003 BACKGROUND

• 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.

  PMID: 20147864 BACKGROUND

• Ramos A, Rodriguez C, Martinez-Beneyto P, Perez D, Gault A, Falcon JC, Boyle P. Use of telemedicine in the remote programming of cochlear implants. Acta Otolaryngol. 2009 May;129(5):533-40. doi: 10.1080/00016480802294369.

  PMID: 18649152 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 3, 2023
• Study Start: November 5, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

CA (2); US (3)