Level 2
I submitted a reimbursement request to NIHDI, which is eligible. 
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General description
Additional info
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General description (provided by company)
Main purpose
The Nucleus® Smart App is designed specifically for the Nucleus 7 and Kanso 2 Sound Processors to provide a convenient and easy way to tailor hearing to personal preferences, all from a compatible Apple or Android smartphone* or Apple Watch®^.
With the Nucleus Smart App, it is possible to:
• Start wireless streaming from Cochlear True Wireless™ accessories;
• Fine tune a patient’s hearing experience by adjusting master bass, volume and treble;
• Set up notifications to alert the patient if the coil is off;
• Access personalised hearing information with the Hearing Tracker;
• Quickly change programs or volume and check battery life without carrying a separate
Remote Control;
• Get help finding the sound processor if it is misplaced;
• Complete a Remote Check appointment, which is a convenient, at-home testing tool that allows patients to complete a series of tests that are similar to those typically conducted during routine, in-clinic appointment for individuals with a cochlear implant. Remote Check will only be visible in the recipient’s Nucleus Smart App menu if their clinician has assessed their suitability for remote support and have enrolled the individual into the Remote Check program. In addition, the clinician will determine which combination of Remote Check tests assigned to the patient. The Clinician is able to access and review the test results through a secure Portal and inform the patient of the outcome via the Nucleus Smart App.
With the Nucleus Smart App, it is possible to:
• Start wireless streaming from Cochlear True Wireless™ accessories;
• Fine tune a patient’s hearing experience by adjusting master bass, volume and treble;
• Set up notifications to alert the patient if the coil is off;
• Access personalised hearing information with the Hearing Tracker;
• Quickly change programs or volume and check battery life without carrying a separate
Remote Control;
• Get help finding the sound processor if it is misplaced;
• Complete a Remote Check appointment, which is a convenient, at-home testing tool that allows patients to complete a series of tests that are similar to those typically conducted during routine, in-clinic appointment for individuals with a cochlear implant. Remote Check will only be visible in the recipient’s Nucleus Smart App menu if their clinician has assessed their suitability for remote support and have enrolled the individual into the Remote Check program. In addition, the clinician will determine which combination of Remote Check tests assigned to the patient. The Clinician is able to access and review the test results through a secure Portal and inform the patient of the outcome via the Nucleus Smart App.
Target audience
Cochlear users having a Nucleus 7 or Kanso 2 sound processor
Approach
The cochlear implant recipient will download the Nucleus Smart App from their iOS or Android device and create a username and password. Once the account has been verified, the patient can pair their sound processors to the app and subsequently be able to access the features mentioned previously. If the patient is happy to be enrolled into Remote Check, the clinician enrols them via the portal and this allows access to Remote Check via the App. The patient then has to consent to their test data being shared with their clinic and to the terms and conditions. They cannot proceed unless consent is granted. The patient can then complete a Remote Check appointment and submit the results for review.
The Remote Check appointment allows the patient to:
1) Take photos of their implant site
2) Complete a questionnaire regarding their hearing performance
3) Complete a hearing test
4) Complete a speech in noise test
5) Check the function of their device (implant and sound processor)
6) Upload their usage data
The Remote Check appointment allows the patient to:
1) Take photos of their implant site
2) Complete a questionnaire regarding their hearing performance
3) Complete a hearing test
4) Complete a speech in noise test
5) Check the function of their device (implant and sound processor)
6) Upload their usage data
Connectivity to sensors and platforms
The application must be connected to a Nucleus 7 or Kanso 2 sound processor (Cochlear implant)
Financing and pricing model
The Nucleus Smart App is a free app to download for people with a Nucleus 7 or Kanso 2 sound processor together with a compatible device.
The Remote Check feature will only be visible in the recipient’s Nucleus Smart App menu if their clinician has assessed their suitability for remote support and have enrolled the individual into the Remote Check program. In addition, the clinician will determine which combination of Remote Check tests assigned to the patient. Remote Check will be offered at a suitable cost. This will be determined in level 3 of the procedure determined on www.mhealthbelgium.be where we will prove the social economic evidence of Remote Check.
The Remote Check feature will only be visible in the recipient’s Nucleus Smart App menu if their clinician has assessed their suitability for remote support and have enrolled the individual into the Remote Check program. In addition, the clinician will determine which combination of Remote Check tests assigned to the patient. Remote Check will be offered at a suitable cost. This will be determined in level 3 of the procedure determined on www.mhealthbelgium.be where we will prove the social economic evidence of Remote Check.
Pathology
Ear / Nose / Throat
Functions
Remote Clinical Monitoring
Users
Everyone
Child
Teen
Men
Women
Elderly
Clinicians
Additional info
This app temporarily, until October 1, 2024, still carries the old M2 label because the requested ICT criteria were met. For now, no reimbursement request has been submitted for this app so it would no longer fall under level M2 in the new model.
Compliance to M2 criteria
Reimbursement request
Self declaration to 6 ICT criteria
Criterion 1: GDPR app category
Criterion 2: Identification of the user in need of care
Criterion 3: App user authentication
Criterion 4: Verification of therapeutic relationship and informed consent
Criterion 5: Applied interoperability standards
Criterion 6: GDPR compliance
Extra: Secured Messaging
Compliance to M1 criteria
CE certification
Certificate granted on 12/06/2018
Certificate valid till 09/05/2022
Class type of medical device (More info): 2A
ISO Standards:
FAMHP registration and notification
Company registration number at FAMHP: 72100
Product identification code at FAMHP: 832154
General Data Protection Regulation (More info)
Reference publication
Remote Check Test Battery for Cochlear Implant Recipients: Proof of Concept Study
Saji Maruthurkkaraa*, Agnes Allenb, Helen Cullingtonc, Joanne Muffd, Komal Arorae, Susan Johnsonf,
Submitted to International Journal of Audiology Nov 2020
Remote Check for asynchronous remote monitoring and triage of cochlear implant recipients
Saji Maruthurkkaraa*, Sasha Casea and Riaan Rottiera
Submitted to Ear & Hearing Dec 2020
Recipient Feedback Study: Project Elon Questionnaire Data on File 2020.
Remote Check was initially evaluated through a multi-centre study as a proof of concept involving clinicians from 6 Cochlear Implant Centres and approximately 100 cochlear implant recipients. This resulted in the submission to IJA (referenced above). The study demonstrated that the tests used were both usable and sufficiently sensitive to identify over 96% of issues that were also identified by a face to face clinical appointment. The App was then developed in-house in consultation with app developers, audiologists, recipients and psychologists to ensure a user-friendly interface was developed. Remote Check was then evaluated by recipients for user experience and reliability resulting in the submission to Ear and Hearing (referenced above) and the Project Elon recipient feedback. Since receiving CE mark in 2018, the app has undergone extensive evaluation phase involving 60 clinics across 13 countries (8 within the EU) and now has over 1700 cochlear implant patients enrolled (>700 in the EU). Remote Check also received FDA approval in April 2020 and a national design award in 2019.
Saji Maruthurkkaraa*, Agnes Allenb, Helen Cullingtonc, Joanne Muffd, Komal Arorae, Susan Johnsonf,
Submitted to International Journal of Audiology Nov 2020
Remote Check for asynchronous remote monitoring and triage of cochlear implant recipients
Saji Maruthurkkaraa*, Sasha Casea and Riaan Rottiera
Submitted to Ear & Hearing Dec 2020
Recipient Feedback Study: Project Elon Questionnaire Data on File 2020.
Remote Check was initially evaluated through a multi-centre study as a proof of concept involving clinicians from 6 Cochlear Implant Centres and approximately 100 cochlear implant recipients. This resulted in the submission to IJA (referenced above). The study demonstrated that the tests used were both usable and sufficiently sensitive to identify over 96% of issues that were also identified by a face to face clinical appointment. The App was then developed in-house in consultation with app developers, audiologists, recipients and psychologists to ensure a user-friendly interface was developed. Remote Check was then evaluated by recipients for user experience and reliability resulting in the submission to Ear and Hearing (referenced above) and the Project Elon recipient feedback. Since receiving CE mark in 2018, the app has undergone extensive evaluation phase involving 60 clinics across 13 countries (8 within the EU) and now has over 1700 cochlear implant patients enrolled (>700 in the EU). Remote Check also received FDA approval in April 2020 and a national design award in 2019.
User instructions
The Nucleus Smart App is compatible with iPhone 5 (or later) and sixth generation iPod devices (or later) running iOS 11.0 or later. To use the Nucleus Smart App on Android mobile devices, Android 5.0 (Lollipop) or later must be installed. The device must also support Bluetooth 4.0 or later. Verified devices can be found at http://www.nucleussmartapp.com/android.
Before using the Nucleus Smart App, the compatible mobile device must be paired to a CI-patient’s Nucleus 7 or Kanso 2 sound processor.
Before using the Nucleus Smart App, the compatible mobile device must be paired to a CI-patient’s Nucleus 7 or Kanso 2 sound processor.
Components of the application
Native app
Complaints handling
Via e-mail: customerservice.bnl@cochlear.comVia telephone: +32 (0)1579 55 77
Media
