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

NCT04987021 | Completed Results

• 1 other identifier: CLTD5809
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cochlear Implant; Remote Programming; Tele-audiology; Tele-medicine

Outcome Measures

Primary Outcomes (1)

• 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)

  Usability rating scale: 1 = unable to complete; 2 = Completed after help using document; 3 = Completed after trying an incorrect option; 4 = Completed after some exploration; 5 = Complete at first attempt.

  Immediately after the participants´ first use of the Nucleus Smart App with Remote Assist Custom Sound Pro 6.3, on average half an hour after participants have completed all tasks.

Study Arms (1)

Nucleus Smart App with Remote Assist Custom Sound Pro 6.3

EXPERIMENTAL

Remote Assist Custom Sound Pro 6.3 to enable clinicians to use the App to remotely to program the recipients sound processors.

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

Interventions

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

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

Nucleus Smart App with Remote Assist Custom Sound Pro 6.3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (1)

Cochlear Sydney In-house lab

Sydney, New South Wales, 2109, Australia

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Results Point of Contact

• Title: PRS Specialist, Clinical Affairs
• Organization: Cochlear Limited

cltd-prs-admin@cochlear.com

+612 9428 6555

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 3, 2021
• Study Start: August 27, 2021
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: February 21, 2024
• Results First Posted: February 21, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)