Simple Ear is not considered a hearing aid. Hearing aids can only be sold by an audiologist or a licensed hearing instrument specialist after hearing tests and fitting appointments. Once they have you tested and fitted, you could pay as much as $5000 for the product.
Simple Ear Basic, Advanced and Premium hearing devices are not hearing aids but rather classified as Personal Sound Amplifiers Products (PSAP). While some of the technology and function of hearing aids and Personal Sound Amplifier Products may be similar, our goal is to provide hearing amplification for recreational, social, and business use.
Our high quality devices are not hearing aids requiring a medical prescription, but rather considered non-medical audio and sound enhancers. Decades of experience, research and development make it possible to pre-adjust the PSAPs in the factory and to immediately provide our customers with an attractively-priced solution without the need for consultation and complex adjustments.
Per the US Federal Drug Administration, PSAPs are intended to amplify environmental sound for non-hearing impaired consumers. They are not intended to compensate for hearing impairment. Examples of situations in which PSAPs typically are used include watching TV, out at a social gathering or restaurant, in a meeting, bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult to hear (e.g., distant conversations, performances).
Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Food, Drug and Cosmetic Act. As such, there is no regulatory classification, product code, or definition for these products.
If you have or think you may have any one of the following symptoms, do not use this product until you have consulted a physician:
- History of excessive wax build-up
- Pain or discomfort in the ear
- Fluid or drainage from the ear within the past 90 days
- Ear canal blockage, a lasting ear infection, or a plugged up fullness feeling
- Visible deformity of the ear
- Sudden, rapidly progressing, or fluctuating hearing loss within past 90 days
- Chronic difficulty hearing
- Ringing in only one ear
- Hearing loss only in one ear that has worsened in the past 90 days
- Spells of acute or chronic dizziness
Keep all parts of the Simple Ear device away from children and toddlers and those under 3 years old. These components contain small parts that may present a choking hazard. This product is not intended for use by minors under the age of 18.