MED-EL Remote Care Multi-Center Feasibility Study

Hearing Loss, Sensorineural Clinical Trial

Official title:

MED-EL Remote Care Multi-Center Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05973669
• Other study ID #: US2302 MED-EL Remote Care
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2025

Study information

• Verified date: June 2024
• Source: Med-El Corporation
• Contact: MED-EL Corporation
• Phone: 1-888-633-3524
• Email: research.us[@]medel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This prospective multicenter study will include MED-EL cochlear implant users from the US and Canada. This study will assess the effectiveness, efficiencies, and useability of MED-EL Remote Care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• MED-EL Remote Care
Remote cochlear implant support

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Med-El Corporation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remote Care Completion	Number and proportion of fully completed Remote Care visits.	Up to 6 months post-training
Primary	Functional hearing	Number and proportion of hearing changes detected using Remote Care.	Up to 6 months post-training
Primary	Telemetry	Number and proportion of telemetry changes detected using Remote Care.	Up to 6 months post-training
Primary	Audio processor equipment	Number and proportion of equipment issues detected using Remote Care.	Up to 6 months post-training
Secondary	Patient time savings	Average patient-reported time estimates associated with attending an in-clinic appointment compared to Remote Care completion time.	Up to 6 months post-training
Secondary	Patient estimates costs	Descriptive summaries of patient-estimated costs associated with attending an in-clinic appointment.	Up to 6 months post-training
Secondary	Clinician time savings	Average clinician-reported time estimates associated with in-clinic appointments compared to Remote Care completion time.	Up to 6 months post-training
Secondary	Patient Feedback Survey	Subject satisfaction measured using a custom questionnaire administered after each use of Remote Care. Each item is scored using a 5-point Likert scale with 1 always indicating a negative response and 5 a positive response. A total higher score indicates higher satisfaction.	Up to 6 months post-training
Secondary	Clinician Feedback Survey	Clinician satisfaction measured using a custom questionnaire administered at mid-enrollment and at study completion. Each item is scored using a 5-point Likert scale with 1 always indicating a negative response and 5 a positive response. A total higher score indicates higher satisfaction.	Mid-enrollment to enrollment completion
Secondary	Remote hearing assessments	Average remote hearing assessment results compared to standard aided test results obtained at baseline.	Up to 6 months post-training