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Version: 1.5.4 

Address: 63-66 Hatton Garden, London, England, EC1N 8LE 

Email: support@eargym.world 

Website: https://www.eargym.world/​

Basic UDI-DI: 50700034104eargymJS

Regulatory References

ISO 13485:2016 | 4.2.3

ISO 20417:2021 | All

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eargym is a Class I medical device in accordance with the UK Medical Devices Regulations 2002.

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eargym is a Class I medical device in accordance with the Medical Device Regulations (EU) 2017/745.

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Product Description

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Intended Medical Indication

eargym is a smartphone application (‘app’), standalone software as a medical device, which is intended to be used to identify bilateral ‘sensorineural’ hearing loss (ICD-10: H90.3) in individuals aged 16+ (see Exclusions). Sensorineural hearing loss is a type of hearing loss caused by damage to the structures in the inner ear or the auditory nerve. The device comprises several components with different benefits and risks:

 

A - Screening Capability - Detection of Potential Hearing Loss:


(i)Through the ‘hearing loss check’, the eargym app indicates to users whether potential hearing loss is detected. The eargym app ‘hearing loss check’ is based on the clinically-validated Digit Triplet Test and screens for signs of hearing loss, measuring the user’s ability to detect and interpret speech in noisy environments. The eargym app hearing loss check is a low-cost, easy-to-use, accessible screening test for potential hearing loss, and is not intended to provide a diagnosis of hearing loss. If potential hearing loss is detected, users are recommended to check the result by taking the Hearing Loss Check again. If the user identifies potential hearing loss through the eargym app, they should seek medical advice and or receive formal audiological assessment from a qualified healthcare professional, such as a GP or qualified audiologist as shown in the image below:

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Image of eargym app and our hearing loss check

eargym User Manual

B - Other Features within the ‘Check’ Tab of the eargym App:

 

(iI) The eargym app’s ‘hearing profile check’ is based on the (modified) Amsterdam Inventory for Auditory Disability and Handicap (mAIAD) and checks for strengths and weaknesses in users hearing, measuring hearing skills and their impact on users’ quality of life. ‘Modified’ is part of the name of this test, it has not been modified by eargym. 

 

(iiI) The eargym app also offers an ‘ear age check’ which is a tool developed to provoke users to think about their hearing health and subsequently use the in-app screener (‘Hearing Loss Check’). The ‘ear age check’ does not contribute to the detection of potential hearing loss, and is not medically-indicated. 

 

(iv) The eargym app also offers a ‘social well-being check’ using the Lubben's Social Network Scale to check current levels of social engagement. 

 

(v) The app also provides a ‘general well-being check’, which is designed by the Office for National Statistics and can give users an insight into their quality of life.

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C - Auditory Training Games and ‘Track Your Progress’ feature:

 

Alongside the hearing checks, the eargym app offers multiple immersive auditory training games to improve core auditory processing skills; the games collectively test 5 core hearing skills which are detection (the ability to perceive the presence of a sound), discrimination (the ability to distinguish between different sounds), localisation (the ability to identify the direction and distance of a sound source), intelligibility in silence and intelligibility in noise (the ability to understand speech when there is no background noise or to understand speech in the presence of background noise). Research evidence is predominantly around practising intelligibility in noise, although as we are trying to build awareness we build games which help users to practise detection, discrimination, and localisation as well.

 

These games are:

(v)  ‘Busy Barista’ trains speech intelligibility and involves listening to various talkers at different intensities in a variety of distracting noises within a ​​café setting. 

 

(vi) ‘Odd One Out’ is a memory based game that trains discrimination skills and involves identifying a sound  (pitch, loudness and silent gaps) which is different from the rest.

 

(vii)  ‘Sound Seeker’ trains detection and localisation skills and involves detecting and perceiving spatial characteristics of sounds like distance, direction, and their position relative to users. 

 

(ix) ‘Petal Picker’ trains horizontal localisation and involves detecting and perceiving the correct position for sound from left to right. 

 

(x) ‘Tone Tap’ trains discrimination and working memory skills through links as many same-sounding tiles together. 

 

All games provide in-game instructions and tutorials for first-time users for full accessibility. The auditory games are intended to be used to practise listening and to maintain healthy hearing, and therefore are management tools and not a form of treatment. 

 

The training games (items (v)-(x) above) adapt to users’ performance for maximum impact; The training games algorithm is based on an adaptive procedure method which adjusts the user's difficulty level depending on their performance, and this adjustment is also dependent on the type of game and hearing skill. This means that each session is personalised to the user, ensuring a continuous challenge to both their hearing and cognitive skills. Users can track the impact of their training using the auditory processing games with the ‘Track your progress’ feature which simulates understanding speech in noisy environments. Benefits are likely to be greater for those aged 35 and above which is when individuals typically begin to notice an age-related hearing deficit. If users’ scores decline after completing the ‘Track your progress’ feature, we suggest that users complete more sessions of the training games to improve.


Please see the specific exclusions and safety warnings below. In particular, please note that the eargym app cannot detect hearing loss in only one ear (unilateral hearing loss) which could be a sign of a more serious underlying condition. Users who suspect they have hearing loss in one ear, have bleeding or discharge from their ears, who have sudden onset hearing loss (noticeable within the last 30 days) or who are worried about their hearing should consult a qualified healthcare professional, such as their GP or audiologist.

Characterisation of User Profile

Users of the eargym app are individuals aged 16+ primarily interested in using the hearing checks to assess their hearing health and to screen for potential hearing loss. Users age 16+ may also be able to improve their listening skills and maintain healthy cognition through the auditory training games. 

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Users of the eargym app have varying levels of pre-existing knowledge in the field of hearing health, from none at all to some knowledge. Some users are familiar with the concept of hearing loss, auditory training and the importance of maintaining healthy hearing protection. Some users are completely new to these concepts, and therefore the eargym app is designed to be user-friendly with no prior knowledge and minimal technical proficiency necessary (can use a smartphone or use one with assistance). Within each menu of the app e.g ‘check’ or ‘train’ there is available information to explain what is being tested, and clear instructions are provided for each check and auditory game. The eargym app is intended to be used only by people who can communicate competently in written/spoken English language and who are competent at using a mobile phone and headphones. If users need assistance using the eargym app, they can get help from someone else. The eargym app has clear instructions and easy navigation, which can be communicated to the user inquiring any assistance.

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Checks are recommended to be taken once every 3 months (approximately 10 minutes in total); users are recommended to train 2-4 times each week and therefore the typical users will use the app ranging between 5-30 minutes within a week period.

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Characterisation of Patient Population

The eargym app is intended to be used by individuals aged 16+ interested in checking their hearing health and improving their listening. Our primary target age demographic is 35-65 year olds (usually when individuals begin to notice deficits with their hearing). 

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The app can be used by those who are and are not experiencing hearing loss (sensorineural), users with hearing aids, users with tinnitus (depending on severity and occurrence).

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Characterisation of Use Environment Including Software / Hardware

The eargym app is to be used in a quiet environment, so that the audio can be easily heard. Headphones are recommended and the app volume should be set so you can hear the app audio at a low and comfortable level.

 

The eargym app is available on iOS and Android devices with a minimum screen size of 5.4 inches and running either iOS 12.1+ or Android 10+. The eargym app is not supported using a tablet as it defaults to mobile layout which impacts the UI/UX.

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Exclusions

The eargym ‘hearing loss check’ is intended for individuals aged 16+ with healthy cognition and therefore is not intended for individuals with additional complexities such as diagnosed or suspected dementia, any form of cognitive impairment including Mild Cognitive Impairment (MCI), reduced cognitive function, those with adult learning difficulties or intellectual disabilities.

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The eargym app, specifically the ‘hearing loss check’ is diotic i.e., it presents an identical sound bilaterally. The ‘hearing loss check’ is presented at suprathreshold intensities; thus, it is insensitive to the attenuation caused by conductive hearing loss (CHL). Individuals with a CHL should not use the eargym ‘hearing loss check’ to screen or monitor their hearing. Due to the hearing loss check’s diotic presentation, it is not suitable for individuals who have been diagnosed with or report to perceive a unilateral or asymmetrical hearing loss, regardless of the aetiology.

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The eargym ‘hearing loss check’ is not suitable for individuals with:

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If individual’s report any of the following, they should consult a healthcare professional before using the eargym ‘hearing loss check’:

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  • A sudden (within 72 hours) onset of hearing loss or a rapid (90 days or less) worsening of hearing in one or both ears

  • Fluctuating hearing (that is not associated with an upper respiratory tract infection - https://www.nhs.uk/conditions/respiratory-tract-infection/)

  • Hearing loss due to lesions of the acoustic nerve or central auditory pathway

  • Vertigo (https://www.nhs.uk/conditions/vertigo/)

  • Head or neck injury/trauma

  • Hyperacusis (noise sensitivity) 

  • Persistent, pulsatile, changing, or distressing tinnitus (https://www.nhs.uk/conditions/tinnitus/).

  • Unilateral tinnitus (tinnitus in one ear only)

  • Otalgia (pain in or around the ears)

  • Otorrhea (any discharge from the ear, which can include water, pus, blood)

 

The eargym 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 well-being while using the eargym app, and it is the user’s responsibility to use the app in appropriate settings. For example, the eargym app should not be used when distractions from mobile phone use could be dangerous, such as crossing the road or driving a car.

The eargym app is to be used in a quiet environment, headphones are recommended and the device volume should be set so you can hear the device audio at a comfortable level.

Safety Information

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Contraindications

eargym provides a ‘Hearing Health Report’ which is personalised for each user, detailing a summary of results collected from their interactions with the app, for instance, if potential hearing loss is detected, whether users' hearing ability may be impacting everyday life, etc. If users have concerns about their hearing, they are advised to consult a qualified healthcare professional, such as their GP or an audiologist.​

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Warning and Remaining Risks

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

 

  • Checking your hearing or training in a loud environment can cause inaccurate results (e.g. false positive or false negative): the eargym app is intended to be used in a quiet environment. 

 

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

 

  • Any interrupted hearing checks and/or training games can provide inaccurate results: the eargym app requires users’ undivided attention from start to finish. 

 

  • Users’ should naturally and honestly use the eargym app: the output of the eargym 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 personalised.

 

  • Users should be aware that on very rare occasions users’ ‘hearing loss check’ results may be inaccurate due to software error (false positives - hearing loss is detected when it is not applicable and false negative - hearing loss is not detected when it is present). If users receive a result of ‘hearing loss detected’, they should take the ‘hearing loss check’ again, and consult a qualified GP or hearing health professional. If users have concerns about their hearing health they should see a qualified GP or hearing health professional.

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Language

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

System Requirements

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Hardware

Users must use Apple (IOS) or Android devices with the required software operating system to use the app (see Software below). Devices to utilise the app require a minimum screen size of 5.4 inches. The eargym app is not supported using a tablet as it defaults to mobile layout which impacts the UI/UX.

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Software

The app is only available on iOS and Android devices with either iOS 12.1+ or Android 10+.

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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 a third party (Google, Facebook, or Apple) where multi-factor authentication can be enabled for additional security.

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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

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Prior IT integration

Headphones are recommended to be used with the app, therefore any external bluetooth headphones need to be connected to the user’s smartphone prior to using the app - this also applies to bluetooth-compatible hearing aids. 

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

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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. 

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How Login Credentials Are Dealt With

Users can continue as a guest or create an account with eargym with an email address and password, this can also be through a third party account authentication (e.g. Google).

Safety and Maintenance

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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.​​​​

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Backend Updates

These updates (e.g data processing, etc.) will be managed by the eargym app team. 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.

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User Reporting

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Malfunctions and Clinical Incidents:

Users can report malfunctions and clinical incidents by contacting the eargym support team directly through the app within the ‘Help & Resources’ section of ‘Account & Settings’. 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.

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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.

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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.

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Yellow Card Scheme:

Adverse events involving medical devices in England and Wales should be reported using the Yellow Card scheme; more regarding the Yellow Card scheme and where users can report incidents or concerns can be found here.

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General User Reporting:

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

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Using the Software

eargym provides comprehensive instructions; these explain all functionality within the app, including how to complete the hearing checks, perform the hearing tests, play the auditory processing training games and access the ‘discover’ material (learning material and sounds). An added feature of the auditory processing training games is that users are introduced to the games with a tutorial so they can get comfortable with the software before testing their auditory ability. Extensive information surrounding the hearing checks and auditory processing games are provided to educate users as to why eargym 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 eargym.

 

Whenever users use the eargym 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 eargym app, personal information about them, the hearing checks and training are saved so that users can be provided with a personalised experience (personalised recommendations and personalised tracking of progress and changes in hearing health).

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Algorithm:

The ‘hearing loss check’ is a behavioural procedure, meaning that the results are based upon a user’s actions. The ‘hearing loss check’ also has an adaptive procedure using the 1-up, 1-down method which adjusts the difficulty of a task (hearing the three digits against background noise) based on the user’s performance (correct or incorrect trials).

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Alternative Services

Users may occasionally be directed to alternative services including healthcare professionals specialising in hearing care (audiologists) - links and resources are provided in the app where required. These services are provided by trusted third parties selected by eargym, however eargym does not take responsibility for the content or provision of third party services. Such services may involve data processing by these third parties, and the user is responsible for disclosure of their data to third parties, which are governed by the third party’s privacy policies.

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