The Food and Drug Administration’s August Ruling
On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) August ruling allowing for the purchase of over-the-counter (OTC) hearing aids went into effect. This exciting development has been in the works since 2017. The FDA Reauthorization Act of 2017 directed the FDA to create a category of over-the-counter hearing aids for adults with perceived mild to moderate hearing loss. Over-the-counter hearing aids are an alternative to prescription hearing aids available through an audiologist. When considering one’s hearing instrument options, it’s important to keep in mind what sets prescription and non-prescription options apart.
Over-the-Counter Hearing Devices:
OTC hearing instruments are for individuals 18 years or older with a perceived mild to moderate hearing loss. An OTC device is not appropriate for an individual less than 18 years of age. Furthermore, an OTC device is not for hearing loss greater than a moderate degree of loss, which would be greater than 55 dB HL on one’s audiogram. However, purchasing an OTC option will not require a formal audiometric test. One may purchase OTC devices to help their perceived mild to moderate loss, which may be approximated through self-tests, tools and software.
In terms of the different designs of OTC devices, all options will be non-customizable and one-size-fits-most. There are both behind-the-ear and in-the-ear styles of OTC hearing devices. The cost of OTC devices is less than $1,000 a pair on average. Following the purchase of an OTC hearing device at a retail store or online, one will self-fit the device. Many OTC devices offer an app that allows one to adjust different settings, including bass, treble and the overall volume of the device. Once the device is self-fit, one can make further adjustments on their own in the app if they believe it is necessary. Finally, it is crucial to note that the FDA has not proposed a return policy for OTC device purchases.
Prescription Hearing Devices:
Prescription hearing aids fit by a licensed audiologist differ from OTC devices in that they are for all ages and all degrees of hearing loss. Hearing instruments available through an audiologist are fit according to one’s prescription. The prescription is determined through a comprehensive audiometric assessment conducted in a sound-treated booth. An audiologist will look inside one’s ear with an otoscope to look at the health of the ear canal and eardrum and confirm there is no wax build-up. Next, the audiologist will do a test called tympanometry, which measures the movement of one’s eardrum to confirm the eardrum’s health. Finally, the audiologist will conduct different tests that measure one’s hearing at different pitches and speech understanding. All this information will allow an audiologist to determine if one is a good candidate for hearing instruments and if further evaluations by other health professionals are necessary. The cost of hearing devices through an audiologist varies by technology level and is around $1,000–$7,000 a pair.
If one is a good candidate for hearing aids and would like to try devices, an audiologist will conduct a functional communication assessment. They will then present the options that best meet the needs of the patient, their listening lifestyle and their individual hearing loss. This may include custom earpieces that are fit by taking a mold of one’s ear canal. At the fitting of the devices to one’s prescription, an audiologist will use Real-Ear Measurements (REMs) to verify the amount of amplification of the hearing instruments. They will place a tiny microphone in the ear canal that allows for the measurement of sound close to the eardrum. This ensures that the hearing devices are giving the appropriate amount of amplification at different pitches and volumes. The audiologist will review the care of the devices, connect the device to one’s phone for Bluetooth® streaming and answer any questions or concerns.
After one is fit with their devices, they will return for follow-up appointments with their audiologist. This allows the audiologist and patient to check in and make any fine-tuning adjustments to the hearing aids based on the patient’s experiences and needs. The audiologist can answer any additional questions about the devices at that time. Finally, the return policy of prescription hearing instruments is mandated in most states; in Washington, there is a required 30-day trial period that allows one to return devices within 30 days of the date of purchase.
Over-the-counter hearing instruments are an exciting option that is helping increase access to hearing health care in the United States. If you or someone close to you is unsure if they are a good candidate for an OTC device, a formal audiometric evaluation is an excellent first step!