Clinical trial NCT05973669: MED-EL Remote Care Multi-Center Feasibility Study
Official title: MED-EL Remote Care Multi-Center Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Sensorineural
Cochlear Implant
Cochlear Implant Recipients
Hearing Disorders
Cochlear Implants
Keywords: cochlear implants
telehealth
remote care
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2023-08-03
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Remote Care Completion
timeFrame: Up to 6 months post-training
Secondary outcomes:
measure: Patient time savings
timeFrame: Up to 6 months post-training
measure: Patient cost estimates
timeFrame: Up to 6 months post-training
measure: Clinician time savings
timeFrame: Up to 6 months post-training
measure: Patient Feedback Survey
timeFrame: Up to 6 months post-training
measure: Clinician Feedback Survey
timeFrame: Mid-enrollment to enrollment completion
measure: Remote hearing assessments
timeFrame: Up to 6 months post-training
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chapel HIll
country: United States
facility: University of North Carolina
state: North Carolina
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.