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Petralex hearing aid developer can not guarantee a comparable level of quality with Bluetooth, such as:
Supported / unsupported Bluetooth-enabled Bluetooth devices.**
Delay in transmission and playback of sound, determined by the features of your use of a smartphone / Bluetooth device and features a Bluetooth profile.
** The possibility / not the possibility of capturing sound by the microphone of a smartphone depends on the model / version of the Android OS of your phone.
When choosing a suitable Bluetooth device, the developer recommends that you first study the list of recommended Bluetooth devices for your smartphone and get acquainted with the technical information published by manufacturers and independent experts regarding the delay of sound transmission.
Petralex can be classified as class I air-conduction hearing aids under 21 CFR 874.3300(b)(1) and class II wireless air-conduction hearing aids under 21 CFR 874.3305, where hearing aids mean “any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing,” as defined in 21 CFR 801.420(a)(1).FDA regulations require that all prospective hearing aid users must have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) within the 6 months prior to the hearing aid dispensation. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists or otorhinolaryngologists. The purpose of the medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased.Individuals 18 years of age and older may waive the requirement for a medical evaluation by signing a waiver statement.You should consult promptly with a licensed physician (preferably an ear specialist) before using Petralex if you have any of the following conditions:
- Visible congenital or traumatic deformity of the ear.
- History of active drainage from the ear within the previous 90 days.
- History of sudden or rapidly progressive hearing loss within the previous90 days.
- Acute or chronic dizziness.
- Unilateral hearing loss of sudden or recent onset within the previous 90 days.
- Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1000 Hz, and 2000 Hz.
- Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
- Pain or discomfort in the ear.
Due to the specific needs and health concerns associated with children with hearing loss, we believe that the medical evaluation requirement should continue to be enforced for all prospective hearing aid users younger than 18 years of age.
If you press to accept then you confirm that you have read all the recommendations and also confirm that you are 18 years of age and older and you waive the requirement for a medical evaluation.
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