N/A N=15 Supportive Care

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

Hearing Loss, Sensorineural · Hearing Loss, Bilateral

Bottom Line

View on ClinicalTrials.gov: NCT04987021 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Number of Participants Who While Using the Final Version of Remote Assist, Are Able to Complete the Primary Tasks (Score of 5 on the Usability Rating Scale) — 13 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cochlear
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who While Using the Final Version of Remote Assist, Are Able to Complete the Primary Tasks (Score of 5 on the Usability Rating Scale)	13	—

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.

Eligibility Criteria

Inclusion Criteria

Adults (≥18 years).
Implanted with the below cochlear implants in one or both ears. CI500 series (CI512, CI513, CI522, CI532,), CI600 series (CI612, CI622, CI632), Freedom series (CI24RE (ST), CI24RE (CA), CI24RE (CS), CI422).
At least 3 months experience with the cochlear implant.
Willing and able to provide written informed consent.

Exclusion Criteria

Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
Currently participating or participated in another interventional clinical study/trial in the past 30 days, or if less than 30 days the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04987021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.