The FrenchEar hearing management system including the FE1+ universal acoustic solution, the OtoCCS all-in-one station and the hearing health platform are licensed products. FrenchEar grants intellectual property rights for the manufacturing and distribution of its hardware and software solutions.

The first version of the FE1+ universal acoustic solution is not a medical device. It is therefore not a Hearing Aid (HA) for which an FDA 501 (k) marketing authorization is required. As the regulation on Hearing Aid Over-The-Counter (HA OTC) was not stopped prior to June 2020, the first version of the universal acoustic solution FE1+ is therefore classified as a Personal Sound Amplification Product (PSAP).

NB : PSAPs are over-the-counter, wearable electronic devices that are designed to accentuate listening in certain environments. They are generally designed to provide some modest amplification of environmental sounds. PSAPs are subject to applicable provisions of the Radiation Control for Health and Safety Act of 1968, under which FDA regulates electronic products that emit sonic vibrations, such as sound amplification equipment. (See also 21 CFR 1000.15.) Manufacturers of PSAPs must report defects and adverse events and take other measures described in 21 CFR Part 1003. Manufacturers of PSAPs must also comply with the requirements to repurchase, repair, or replace electronic products required under 21 CFR Part 1004.

Analog amplification has the advantage of offering an extremely natural sound without any signal processing delay. It has been the standard in audiology for decades and is missing today within the landscape of digital hearing aids. While customizable, the latter generate a sound described by the hearing impaired as being often robotic / metallic. FrenchEar is moving away from this and has integrated an analog and active noise reducer as well as an automatic gain control into its device.

The FE1+ universal acoustic solution is a self-fit programmable hearing device whose presets have been optimized and precisely calibrated to be consistent with the vast majority of people with listening difficulties, including age-related difficulties of intelligibility. The system not specifically been developed for severe or profound deafness.

The FE1+ Universal Acoustic Solution comes with 3 different size clip-on miniaturized speaker and ear domes in varying sizes. Adjustability is accomplished thanks to a dedicated template.

Yes. It is recognized by the FrenchEar mobile application and is part of the packaging for the FrenchEar hearing management system.

Simply press the on / off button and place the dome and microphone of the FE1+ universal acoustic solution against the suction nozzle, both exposed to wax and sometimes to dust. After several suction cycles, the removable tank must be emptied and cleaned.

Yes, both the ear device and the station have Bluetooth 5.0.

A guide to getting the most out of your FrenchEar FE1+ Universal Acoustic Solution .

1. Managing your out-of-the-box FE1+ hearing device expectations. People who wear their hearing devices are regularly more successful in retraining their brains to hear the sounds they have been missing. Sometimes it takes several months to fully adapt. And, just like wearing glasses for the first time, you will adjust to your hearing device after you go through the adjustment period. Infrequent use of your hearing device is a major barrier to adaptation and will not allow you to attain the full benefits of the hearing device. Your brain needs substantial exposure to sounds and time to learn how to handle it again.

2. Don’t expect perfect hearing immediately and right out-of-the-box. The FE1+ hearing device is a valuable tool to help you hear better but will not restore the full function of normal hearing, especially during the first few weeks. Hearing devices are supposed to maximize the hearing you have left with an emphasis on speech enhancement. Even with the most advanced hearing technology available and customization, you are likely to have difficulty hearing in challenging situations such as noisy restaurants. Keep in mind that even people with great hearing will have trouble hearing every word of a conversation in a challenging environment.

3. Do expect to wear your FE1+ hearing device consistently for most waking hours. If you are a first-time user, you should start with 2-4 hours a day, then gradually increase to 8 hours per day minimum. Do expect your hearing device to be comfortable to wear and you should never experience pain or soreness. If uncomfortable, remove the hearing device immediately and try a smaller ear tip. If the pain persists or other issues arise, contact the local hearing car provider for additional advice.

4. It takes practice — and patience — to acclimate to your new hearing experience. The FE1+ hearing device are state-of-the-art analog hybrid devices – which means they process sound fully analog and even if they cannot be highly customized by a computer for your individual hearing, you should expect to hear many soft sounds again, and louder sounds should be pleasant and comfortable thanks to the Active Noise Cancelling (ANC) and the Active Gain Output (AGC).

5. By wearing your FE1+ hearing device, your soundscape will be amplified. There are some parameters on which you will be able to do little or nothing, which will directly influence your intelligibility and that you must keep in mind if momentarily your understanding appears to you as difficult.

– The distance between you and your interlocutor. After only a few meters of propagation, the sound waves of the voice quickly lose their sharpness. If you are talking about a room to another for example, it may be that the clarity of the words is average simply because of the great distance between you and your interlocutor.

– The speech of your interlocutor. There are always voices that we hear better than others. When someone does not articulate, does not make pronunciation effort, speaks very low or very loudly, he can create a very degraded spectral envelope of his own voice and this one is amplified with fidelity by the hearing aid that you wear, it can result in a medium intelligibility.

– The acoustics of the building or room. Some places resonate more than others. If there is a lot of reverberation (for example in a church, a big room, a kitchen, a bathroom etc), the sharpness of the sound information coming to you can be very degraded and directly harming your comprehension.

– The presence of surrounding noises. The louder the sound environment you are exposed to, the more useful the voicemail message you want to hear will be disturbed by the complexity of the spurious sound waves.

6. Hearing sounds you have been missing for years can be challenging. It is likely that it has been years since you heard all the sounds around you. From the faint sounds of keyboard clicks, bird chips, humming of the refrigerator and air conditioning unit, to the sound of your shoes hitting the floor as you walk. These sounds may be unfamiliar and even annoying at first. With practice and patience, the annoyance will magically “disappear” as your brain learns to adapt and process them as normal. Think of the experience you get walking out from a dark room to the bright outdoor. Your ears, like your eyes, need time to adjust to the “brighter” stimulation. Also, think of what happens when you try to exercise after not being active for a while. Like your muscles, your ears need to adapt to the work they are being asked to do again.

7. When you first begin wearing your FE1+ hearing device, your own voice may sound different, and even funny. This is because hearing devices also amplify your own voice. Some have compared the sensation of hearing their own voice through their hearing device to hearing a recording of themselves. While a hearing device is optimized for speech, it will amplify all sounds in that range, and that includes your own voice. The hearing device may occlude or plug your ear canal which can also make your voice sound different. This is known as the occlusion effect — sounding like you’re in a barrel – and it takes few days to adjust. If your own voice continues to sound funny – you may try a different ear tip. An assortment of ear tips is included in your hearing device kit.

8. Whistling or feedback may be experienced momentarily as your hearing device settles in the ear, or when you cup your hand over your ear. However, the hearing device should not continue to whistle when properly secured in your ears. If whistling continues when the device is worn in your ear, you may want to try a different ear tip that fits more securely and provides a better seal in your ear canal. A loose ear tip in the ear is the major cause of whistling and moving up to a larger tip size, or switching to an unvented type ear tip, may make all the difference in controlling the whistling. Always make sure the ear tip is securely attached to the hearing device before you insert the earpiece in the ear. Make sure your ears are clear of wax and other debris. Adjusting the setting of your hearing device is another option.

9. Tips to speed up the adaptation process:
– Wear your hearing devices only in quiet environments during the first few days.
– Wear them only a few hours a day during the first week.
– Read to yourself out loud for 10 minutes or so to help you get used to the sound of your own voice again
– Practice by listening to your TV or having a conversation with a family member.
– Take breaks by removing the hearing device when you feel tired or overwhelmed by the new sound experience.
– Set realistic expectations; hearing devices will not restore your hearing to normal — but they will make a big difference in your hearing ability.
– Most importantly : be patient and practice. Allow your brain to adapt.

10. What to Expect by the end of the 45-day trial period:
– Your ability to hear and understand others should be improved
– Hearing and communicating in quiet environments should noticeably be improved
– Hearing in noisy environments should also be improved, but expect some challenges (as we all find these settings challenging).
– You should adjust to your own voice, but it should not continue to be annoying.
– The intensity and quality of sounds should be sharper, brighter and clearer — but not irritating.
– Wearing hearing devices in both ears should improve your hearing ability, help you identify the location of each sound, and improve speech perception in noisy conditions. Our brains are designed to use both ears, not one. If you have a hearing loss on both ears, you really should be using a pair of hearing devices.

11. What are the contraindications (preventive medical conditions) ? The FDA and many State regulations require that you either get a medical examination and prescription from a physician before you purchase a hearing aid, or sign a waiver (available online) stating that you decline a medical examination. Please read the following list of conditions carefully. If you know, or were informed by a physician that you have any of the following conditions, you will need a medical clearance (prescription) by a physician before using the FE1+ hearing device :

– Visible deformity of the ear
– Fluid or drainage (not earwax) from the ear within the past 90 days
– Sudden, rapidly progressing, or changing hearing loss within the past 90 days
– Spells of acute or chronic dizziness
– Hearing loss on one side that worsened in the past 90 days
– A recent or current ear infection, a plugged-up fullness feeling
– A punctured eardrum
– Conductive hearing loss, or air-bone gap
– Excessive wax buildup, or a history of excessive wax buildup
– Foreign object stuck in ear canal
– Pain or discomfort in the ear
– Ringing in one or both ears which began or worsened in the last 90 days

We are focused on privacy and data security. Our HIPAA-compliant platform uses end-to-end encryption to protect access to user data. Our Universal Health Record is own by the user and only him can share an access to his data with someone else.

FrenchEar combines medical and lifestyle information for each individual into a single health record eliminating the need for duplication of general health information, treatments, and medical tests. An individual’s health data resides on a secure server providing security, accessibility, accuracy, and confidentiality, resulting in a totally portable solution for managing health information and records.

This health record allows individuals to have ownership of their health information while giving healthcare professionals medically credible, comprehensive and secure information that is easy to access. Within this health record. FrenchEar has implemented a number of unique features to manage, track and certify data.

• Medical data is flagged to indicate that an accredited Healthcare Professional has certified it.
• All certification is recorded and tracked to ensure medical credibility.
• Certain data may only be entered and updated by accredited Health Care Professionals.

Changes to the individual’s record are tracked and a notification of such changes is sent to the individual.

The scoring/profiling service is a knowledge-based program that allows for the output of an intelligent health profile. This knowledge database has incorporated data from over 38,000 medical reference materials like JAMA, Lancet, and New England Journal of Medicine, etc. By using the FrenchEar individuals are given scores derived from their own raw date entered and that reflect their overall health as compared to their optimal health, not to others. These variables are analyzed by proprietary algorithms and knowledge-based applications. It then outputs a set of health scores grouped in six or seven categories depending on the solution.

A score is a numerical value, generally expressed as a percentage between 0% and 100%. A score represents a health index, and it can be for example a physical condition, mental state, or nutrition information.

These scores can be used by healthcare professionals to design customized health solutions allowing a way to benchmark an individual’s or a given population’s health status on a regular basis. Insurers and corporations can also utilize these scores within their community network to evaluate, underwrite and manage risk, while maintaining each individual’s anonymity.

The audiology score is base on tonal audiometry results which can be tested with an Audiologist or Hearing Care Professional or with the FrenchEar App. FrenchEar based its test on the International Classification of Functioning, Disability and Health (ICID) was proposed by WHO in 2001 and adopted by 200 countries. It crosses the recommendations 02/1 bis of the International Bureau of Audiophonology (or BIAP) on the audiometric classification of hearing impairments, validated on 1/5/1997 in Lisbon.

In a near future, we want to introduce many parameters into our audiology score such as vocal and tonal audiometry tests performed without the hearing device and then with the hearing device.

All FrenchEar products and services are available under license. FrenchEar grants intellectual property rights for the manufacture and distribution of its hardware and software solutions. To find out more, you can consult our License page or contact us using the contact form at the top of the page.

The three main advantages of the license are:

1. Time to market
2. Cost optimization
3. Recurring income

To find out more, you can consult our License page or contact us using the contact form at the top of the page.