Instructions For Use [eargym CI Rehab]

Version: 1.0.0

Address: 167–169 Great Portland Street, 5th Floor, London, W1W 5PF

Email: support@eargym.world 

Website: https://www.eargym.world/

Symbols

Title of the Symbol	Symbol	Meaning
Safety Information		This symbol indicates key safety-related information.
Instructions For Use		This symbol indicates the need for the user to consult the instructions for use.
Manufacturer		This symbol indicates the name and address of the manufacturer.
Medical Device (MD) Symbol		This symbol indicates that we are a medical device.

Medical Device Scope and Regulatory Context

FDA Registered: eargym is a Class II, 510(k)-exempt medical device in accordance with Title 21 of the Code of Federal Regulations.

The eargym CI Rehab app is a standalone software application developed specifically to provide auditory training to cochlear implant users. While separate from the core eargym app which provides hearing checks and auditory training for a broader user population (see eargym app User Manual for more detail), the eargym CI Rehab app falls within the same FDA regulatory scope and registration under FDA product code EPF as a Class II, 510(k)-exempt medical device.

Product Description 

Intended Medical Indication & Use

The eargym CI Rehab app is intended to help users aged 13+ adapt to the sound signals provided by their cochlear implant, to maximize their speech perception abilities. Through structured auditory training games users can practice listening to acclimatize to and get the best out of their cochlear implant. This facilitates adaptation, user engagement, and consistent use of hearing devices, as part of an overall cochlear implant rehabilitation programme directed by a hearing care professional.

These games are:

(i)  ‘Word Wizard’: users listen and identify individual words, helps the user discriminate between different speech sounds.

(ii) ‘Grid Game’: users listen to and identify words in simple sentences with a fixed structure, helps practice your ability to identify individual words in simple sentences. 

(iii)  ‘Sonic sentences’: users listen to and identify individual words in everyday sentences, helps practice your ability to understand sentences like those you might hear in some common real world situations.

(iv) ‘Progress check’ helps the user’s audiologist understand the impact of the training - to be completed before training and unlocked again after 10 games.

All games provide in-game instructions for full accessibility. 

The training games (items (i)-(iv) above) function across 3 key pillars:

Targeted Rehabilitation: fun and training games designed by users and audiologists to facilitate post-implantation auditory rehabilitation.

Neuroplasticity & Adaption: Helping the brain to adapt to the unique challenges of listening through a cochlear implant, helping recipients bridge the gap between device activation and functional hearing.

Adaptive Learning Logic: Powered by a proprietary algorithm that adjusts task difficulty in

real-time based on user performance, ensuring a "just-right" challenge for optimal neural engagement.

Please see the specific exclusions and safety warnings below. 

Characterisation of User Profile

Users of the eargym CI Rehab app are individuals aged 13+ interested in using the app to practice listening to acclimatize to and get the best out of their cochlear implant. The app is designed for users who have received a cochlear implant in the last 18 months.

Users of the app have varying levels of pre-existing knowledge around auditory training. Some users are completely new to this concept, and therefore the eargym CI Rehab app is designed to be user-friendly with no prior knowledge and minimal technical proficiency necessary (can use a smartphone/tablet or use one with assistance). Within the ‘training’ menu there is available information to explain what is being tested, and clear instructions are provided for each game.

The app is intended to be used only by people who can communicate competently in written/spoken English language at an elementary level and who are competent at using a mobile phone/tablet. If users need assistance using the app, they can get help from someone else. The eargym CI Rehab app has clear instructions and easy navigation, which can be communicated to the user inquiring any assistance.

Users are recommended to train for 15-30 minutes 5 days a week, however the optimum may vary from person to person (this may be discussed with an audiologist). Users report benefits in 4-6 weeks.

Characterisation of Patient Population

The eargym CI Rehab app is intended to help users aged 13+ adapt to the sound signals provided by their cochlear implant, to maximize their speech perception abilities. Though structured auditory training games users can practice listening to acclimatise to and get the best out of their cochlear implant. 

The app is designed for users who have received a cochlear implant in the last 18 months.

Characterisation of Use Environment Including Software / Hardware

The eargym CI Rehab app is to be used in a quiet environment, so that the audio can be easily heard. Users can listen to audio via their loudspeaker, however, if possible it is recommended to stream from their phone/tablet to their cochlear implant. App volume should be set so the user can hear the app audio at a low and comfortable level.

The app is available on iOS and Android devices (mobile/tablet), universal screen size, running either iOS 15.0+ or Android 7.1+.

Exclusions

No specific conditions are excluded.

The eargym CI Rehab app is designed to be used only in a safe and controlled environment. It should not be used in situations where distractions could pose a risk to personal safety. Users are responsible for their own safety and wellbeing while using the app, and it is the user’s responsibility to use the app in appropriate settings. For example, the eargym CI Rehab app should not be used when distractions from mobile phone use could be dangerous, such as crossing the road or driving a car. The app is to be used in a quiet environment, and the device volume should be set so the user can hear the device audio at a comfortable level.

Safety Information

Warning and Remaining Risks

Before using the eargym CI Rehab app, users need to be aware of the following precautions and remaining risks:

• Training in a loud environment can cause inaccurate results; the app is intended to be used in a quiet environment. 

• Using the eargym CI Rehab app on a high or very high volume can cause damage to the ears; the app is intended to be used on a low and comfortable volume.

• Any interrupted training games can provide inaccurate results; the app requires users’ undivided attention from start to finish. 

• Users’ should naturally and honestly use the eargym CI Rehab app; the output of the app is intended to be a reflection of an individual's hearing health, any dishonest answering or unnecessary guessing can lead to inaccurate results which will lead to recommendations being inaccurate and not truly personalized.

Language

The eargym CI Rehab app is available in English, and users must be able to read, understand and write competently in the English language at an elementary level in order to use the app safely. 

System Requirements

Hardware

Users must use Apple (IOS) or Android devices with the required software operating system to use the app (see Software below).

Software

The app is available on iOS and Android devices (mobile/tablet), universal screen size, running either iOS 15.0+ or Android 7.1+.

IT-security Measures

Preventing Unauthorised Access:

Users are required to create a password with a minimum of 6 characters and 1 number to protect their account. Users are able to login through email where multi-factor authentication can be enabled for additional security.

Data Protection:

Any sensitive user data, like personal information, is stored in Google’s Firebase database; this data is kept safe with strong security and encryption measures. For more information, please see our Privacy Policy.

Installation

Prior IT integration 

Users can listen to audio via their loudspeaker, however, if possible it is recommended to stream from their phone/tablet to their cochlear impact. App volume should be set so the user can hear the app audio at a low and comfortable level.

Apart from the use of a cochlear implant, no integration with other devices is required, and the app operates on a standalone basis. 

Successful Installation 

Upon installing eargym, users can verify successful installation by checking the app icon is available on their device’s home screen. Another confirmation of a successful installation is encountering a fully functioning app without any errors or crashes.

How Login Credentials Are Dealt With

Users can create an account with the eargym CI rehab app with an email address and password.

Safety and Maintenance

Frontend Updates

User interface improvements and new features updates will be released through the available app stores (i.e., Apple App Store & Google Play). A description of the update will be available on the app stores e.g bugs fixed, etc. Users are notified via email and in-app with an update alert prompting them to download and install the latest version. Major updates are designed to work with all versions of the app but in most cases users are strongly advised to update to the latest version.

Backend Updates

These updates (e.g data processing, etc.) will be managed by eargym. Major and backend updates are tested in staging and production environments first and deployed when stable to ensure the app remains up to date and performs optimally, so the frontend is not impacted.

User Reporting 

Malfunctions and Clinical Incidents:

Users can report malfunctions and clinical incidents by contacting the eargym support team directly through the app within Profile > App Feedback.This will initiate a response from the team to address the issue and provide support and assistance as required. If users cannot access the app the support team can be contacted on the eargym website or users can ask questions to the chat bot which is also on our website.

Lost Passwords:

For lost passwords, users can use the ‘forgotten password’ function within the app’s login screen. This will trigger a password reset, where users will receive instructions via email to make a new password and securely access their account.

Potential Security Breach:

In the event of a potential security breach, users should contact the app support team or directly contact the eargym Data Protection Officer (provided in eargym Privacy Policy). The issue will be investigated and any necessary actions will be taken to protect users’ data.

General User Reporting

Users should report adverse events to the national competent authority in the country in which they reside.

Users should also report adverse events to the manufacturer.

Using the Software

The eargym CI Rehab app provides comprehensive instructions; these explain all functionality within the app, including how to play the auditory training games. Extensive information surrounding the auditory training games are provided to educate users as to why the eargym CI Rehab app is beneficial, the reason for each feature of the app, and any risks to the user to enable them to make an informed choice about the benefits and potential risks of using the app.

Whenever users use the eargym CI Rehab app, information is automatically collected about their usage such as when they have used the app, which features they have used, and for how long. The information generated by their engagement with the app, personal information about them, and the training are saved so that users can be provided with a personalised experience (personalised recommendations and personalised tracking of progress).

Algorithm:

Adaptive Learning Logic: Powered by a proprietary algorithm that adjusts task difficulty in

real-time based on user performance, ensuring a "just-right" challenge for optimal neural engagement.

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