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Hearing Loss, SensorineuralNCT05973669

MED-EL Remote Care Multi-Center Feasibility Study

A study testing MED-EL Remote Care in people with Hearing Loss, Sensorineural and Cochlear Implant, run by Med-El Corporation at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
MED-EL Remote Care
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
5 sitesin 2 countries
Study dates
5 Nov 2024to 11 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States3 sites

  • University of Michigan

    Ann Arbor, Michigan, 48108

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

Other trials in United States

Canada2 sites

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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.

Read the 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.

Being tested
MED-EL Remote Care
Keywords
cochlear implants, telehealth, remote care
Medical subject headings
Hearing Loss, Sensorineural, Hearing Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MED-EL Remote CareDevice

    Remote cochlear implant support

Study groups in NCT05973669
Study groupRoleWhat they receive
Remote cochlear implant supportExperimentalParticipants 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.
Receives: Device: MED-EL Remote Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Remote Care Completion

    Number and proportion of fully completed Remote Care visits.

    Measured: Up to 6 months post-training

Secondary outcomes (6)

  1. Patient time savings

    Average time estimates associated with attending an in-clinic appointment compared to Remote Care completion time.

    Measured: Up to 6 months post-training

  2. Patient cost estimates

    Descriptive summaries of patient-estimated costs associated with attending an in-clinic appointment.

    Measured: Up to 6 months post-training

  3. Clinician time savings

    Average clinician-reported time estimates associated with in-clinic appointments compared to Remote Care completion time.

    Measured: Up to 6 months post-training

  4. 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.

    Measured: Up to 6 months post-training

  5. 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.

    Measured: Mid-enrollment to enrollment completion

  6. Remote hearing assessments

    Average remote hearing assessment results compared to standard aided test results obtained at baseline.

    Measured: Up to 6 months post-training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start5 Nov 2024
  3. Primary completion11 May 2026
  4. Study completion11 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05973669
Sponsor's protocol ID
US2302 MED-EL Remote Care
Status last verified
Jul 2026
First submitted
14 Jul 2023
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 34320523

  • 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.

    PubMed 33555935

  • 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.

    PubMed 30741905

  • 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.

    PubMed 29678970

  • 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.

    PubMed 31056039

  • 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.

    PubMed 30452743

  • 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.

    PubMed 24675003

  • 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.

    PubMed 20147864

  • 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.

    PubMed 18649152

Questions about this trial

What is this clinical trial studying?

A study testing MED-EL Remote Care in people with Hearing Loss, Sensorineural and Cochlear Implant, run by Med-El Corporation at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remote Care Completion (time frame: Up to 6 months post-training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05973669, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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