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An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients

NCT04987021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-02-21

Study results available
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Summary

Clinical management of cochlear implant (CI) recipients involve programming, counselling, performance evaluation and habilitation. This requires the recipients to travel to the clinic for follow up appointments which can pose significant challenges for recipients, particularly those who live far away from the clinic. Remote Assist (RA) is a new solution that allows the clinician to make MAP and sound processor adjustments via the recipient's Nucleus Smart app (NSA) installed on their smart phone. With RA the clinician can also perform counselling using a video call directly via the NSA. As RA uses no specialized hardware and software that needs to be sent and retrieved back from the recipient, it has the potential to further improve the remote programming experience and convenience for both the recipient and the clinician.

Conditions

  • Hearing Loss, Sensorineural
  • Hearing Loss, Bilateral

Interventions

DEVICE

Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants

The Remote Assist (RA) System is intended to support clinicians to conduct a remote programming session with their CI recipients.

Sponsors & Collaborators

  • Cochlear

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2022-01-28
Completion
2022-01-28

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04987021 on ClinicalTrials.gov