Remote Care: The Future of Cochlear Implants

University of Miami

Status: Completed

Conditions: Cochlear Implants

Treatments: Other: remote CI programming

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04721327

20201410

Details and patient eligibility

About

The purpose of this study is to see if remote programming visits for cochlear implants are possible.

Enrollment: 30 patients

Sex: All

Ages: 1 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Pediatric Arm

1. English speaking patients (Parents can speak English and/or Spanish)
2. ages 1-17 years
3. current CI users with a Cochlear Americas device
4. minimum of 6-months of CI experience
5. maximum of 4 years of CI experience

Adult Arm

1. Postlingual patients

2. English speaking patients

3. ages 18-90 years 3. current CI users with a Cochlear Americas device 4. minimum of 3-months of CI experience 5. maximum of 18-months of CI experience

Exclusion criteria

1. Patients with physical neuropathy, abnormal anatomy (e.g., cochlear malformations), severe cognitive deficits, and/or severe mental health difficulties
2. Patients who do not speak English
3. Patients who do not have access to the internet
4. Patients who do not live in Florida
5. Patients who have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Pediatric Arm

Experimental group

Description:

Patient ages 1-17 years who are current cochlear implant (CI) users will receive CI programming in person for the first visit and remotely for the second visit.

Treatment:

Other: remote CI programming

Adult Arm

Experimental group

Description:

Patient ages 18-90 years who are current cochlear implant (CI) users will receive CI programming in person for the first visit and remotely for the second visit.

Treatment:

Other: remote CI programming