Is it OK to buy FDA approved Over-the-counter hearing aids?
OTC Hearing Aids
What is the OTC Hearing Aids?
The OTC hearing aid is short for Over-the-counter hearing aids.They are air-conduction hearing aids that do not require implantation or other surgical intervention. They bring amplified sound into the ear canal. Sound then moves through the eardrum and three tiny bones in the middle ear to reach the inner ear, where it’s processed and sent to the brain.
According to the FDA rule,if you are 18 years of age or older and believe you have perceived mild to moderate hearing loss, you can buy an OTC hearing aid in a store or online without seeing an ear-nose-throat (ENT) doctor, or a licensed hearing health care professional (audiologist).
Are Earsmate OTC Hearing Aids FDA Approved?
Sony CRE-E10: FDA cleared.
Lexie B2: FDA cleared.
Earsmate G39 : FDA registered.
Eargo 7: FDA cleared.
Earsmate G31 : FDA registered.
Sony CRE-C10: FDA cleared.
FDA Rules about the OTC Hearing Aids
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES
PART 874 -- EAR, NOSE, AND THROAT DEVICES
Subpart D - Prosthetic Devices
Sec. 874.3300 Air-conduction hearing aid.
(a) Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.
(b) Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.
[87 FR 50762, Aug. 17, 2022]
With the FDA's issuance of its Final Rules for OTC hearing aids in August 2022, the Agency essentially reorganized air-conduction hearing aids, keeping all of the original categories (including 874.3300 [ESD], 874.3305 [OSM] and 874.3325 [QDD]) and their existing product codes.
As the professional OTC hearing aids supplies from China,we recommend if people with mild to moderate hearing loss who are good candidates for hearing aids bought over the counter without medical exams or professional fittings.
There are two FDA approved Over-the-counter hearing aids you can buy online from the Earsmate hearing aids store with free shipping service.
Earsmate G39 OTC Hearing aids
• Invisible CIC Rechargeable
• Power and Volume switcher
• Adaptive Noise reduction
• Type-C DC5V Charger box
• Fitting Mild to Moderate Hearing Loss
• 2 hours quick charge fully
• Battery work time 20-25 hrs
• 6-7 times recharge for Aids by Charger box
• Red/Blue or Beige color
• FDA,ISO13485,CE FCC RoHS
• 1 Year warranty
More about the Earsmate G39
Earsmate G39 OTC Hearing Aid Invisible In Ear canal For Seniors cuts out the bells and whistles in favor of something simple. The product features no app or Bluetooth and instead relies entirely on manual buttons to turn amplification up or down and switch the device power on or off.
Given their smaller technical footprint, the Earsmate G39 Rechargeable CIC OTC hearing aids have a super longer battery life of any rechargeable hearing aid in market 2023, with an estimated run time of 24 hours per charge. Once adjusted, the hearing aids are the easiest to use out of the box with no additional features to complicate the user experience. Despite this simplicity, the Earsmate G39's sound quality and amplification to be satisfactory. And the Earsmate OTC Hearing Aids G39 is by far one of the least expensive in-the-ear-canal hearing aids tested, priced at $79 only and drop-shipping free service by Express Air way,like DHL/UPS/FedEx of quick shipping, making them highly affordable for most people seeking over-the-counter hearing aids FDA approved.
If all you are looking for is a set-it-and-forget-it hearing aid and are willing to sacrifice modern features like streaming and apps, then the Earsmate G39 may be perfect for you.
Earsmate G31 OTC Hearing aid
• 16CH WDRC Digital Processor
• 2 Aids Right + Left
• 4 Mode + Volume switch by One Key
• Digital Noise reduction
• Fitting Mild to Moderate Hearing Loss
• Battery working 20-25hrs
• 3-4 times recharging by Charger case
• Red/Blue or Beige color Device
• FDA,ISO13485,CE FCC RoHS
• 1 Year warranty
More about the Earsmate G31
The Earsmate G31 are the newest CIC Digital hearing aids supplies by Earsmate that use high quality rechargeable batteries. It is a cut-edge 16 channel wdrc signal processing and invisible in ear canal rechargeable hearing aids. The Earsmate G31 in the list of OTC hearing aids are smaller in size, which could be good for those who want something discreet, but they aren't capable of audio streaming.
Outside those tradeoffs, there are huge benefits to the Earsmate G31 digital hearing aids with regard to longevity, as the lithium-ion batteries used in all rechargeable products are only expected to last 3-5 years with consistent use. In this case, one can keep slotting in new size-10 batteries for as long as they're sold. And each fully charged for the portable charger case can last a whopping 60 hours standby, which means users could feasibly get away to charge the cases just once per week.And the hearing aid battery lifespan is 20 hours by a short 1.5hours fully charged.
Currently priced at $119 per pair only and drop-shipping free service by Express Air way,like DHL/UPS/FedEx of quick shipping, the Earsmate G31 FDA Approved OTC Hearing aids are a budget-conscious hearing option with potential longevity that's impossible for current rechargeable models to match.Moreover,the Earsmate CIC rechargeable digital hearing aids with noise reduction,whistling cancelling and 4 preset listening mode to fit different environment and sound frequency to have a better hearing experience.
