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Exploring the Viability of Over-the-Counter Hearing Aids

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The Basics: Hearing Aids versus Amplification Products

The recent change in FDA regulations has opened up the possibility of over-the-counter (OTC) hearing aids, which has significant implications for the 48 million Americans with hearing loss. Dr. James Naples, an expert in otolaryngology/head and neck surgery at Harvard-affiliated Beth Israel Deaconess Medical Center, provides valuable insights into the potential pros and cons.

Hearing aids, regardless of their style, function by amplifying sounds and filtering out specific types of noise. Dr. Naples explains that all hearing aids utilize signal processing and directional microphones to enhance our ability to hear sounds by reducing unwanted noise.

It's crucial not to confuse prescription or OTC hearing aids with personal sound amplification products (PSAPs) available in drug stores. PSAPs simply amplify nearby sounds and are not tailored to individual hearing loss. They lack regulation by the FDA and are not intended to treat hearing loss. However, they can be a suitable alternative for individuals facing specific challenges, such as difficulty hearing the television.

Will I need a hearing test for an OTC hearing aid?

Typically, individuals would have their hearing tested by a certified audiologist who would then configure hearing aids based on the specific hearing loss. This process resembles getting prescription glasses. Hearing tests determine the volume required for clear sound perception. Individuals with normal hearing can identify sounds below 25 decibels (dB), while mild to moderate hearing loss occurs in the 26 dB to 55 dB range. Those with mild hearing loss may struggle with softer sounds, while individuals with moderate hearing loss can experience difficulty understanding speech at normal levels. It's important to note that hearing loss related to age or other factors can affect one or both ears.

Unlike prescription hearing aids, OTC options do not require a hearing test conducted by an audiologist. However, it's essential to consider that these devices are only suitable for treating mild to moderate hearing loss. Individuals with severe or profound hearing loss should still consult an audiologist for a complete examination.

Will the cost of hearing aids be lower?

The introduction of OTC hearing aids will likely bring about cost savings, although the extent of the savings may vary. While Medicare does not cover hearing aids, some Medicare Advantage plans and other commercial health insurance plans do provide coverage.

The new FDA regulations mean that individuals with mild to moderate hearing loss will no longer need to pay for hearing exams and fittings. However, the most significant savings will be seen in the cost of hearing aids. Although prices for different brands and types of hearing aids can vary, a single prescription hearing aid typically averages around $2,000. For those needing aids in both ears, this means an expense of $4,000, which many individuals encounter.

In the United States, a limited number of companies produce the majority of prescription hearing aids, resulting in high prices driven by a lack of competition. The introduction of OTC hearing devices is expected to increase competition among manufacturers, leading to lower average prices over time. Early estimates suggest that the average price may drop to approximately $1,600 or even lower.

Will OTC hearing aids match the quality of prescription hearing aids?

OTC hearing aids will be regulated by the FDA for product quality, similar to their prescription counterparts. While appearances, styles, and features may vary, they will meet the necessary quality standards.

Are OTC hearing aids suitable for everyone?

It's important to understand that hearing aids are not a one-size-fits-all solution. While OTC devices may benefit many individuals with mild to moderate hearing loss, they may not be appropriate for all types of hearing loss. Dr. Naples compares this to drugstore reading glasses, which are designed to address specific vision problems but have limitations depending on an individual's eyesight. Similarly, OTC hearing aids may have their limitations.

Prescription hearing aids can be individually tailored and fine-tuned to meet specific needs, while OTC devices come in generic sizes that cannot be customized. Additionally, the return policy for OTC devices is still unclear, making it uncertain how repairs, warranties, and replacements will work.

What else should I consider?

Self-prescribing an OTC hearing device may lead to individuals missing out on a proper diagnosis of their hearing loss. Hearing loss can be a symptom of underlying conditions that require evaluation. Dr. Naples emphasizes that a wide range of conditions can cause hearing loss, and distinguishing the cause without an evaluation can be challenging. Therefore, if you experience symptoms such as ear pain, dizziness, vertigo, hearing loss in only one ear, or ringing in the ear, it is crucial to seek medical evaluation in addition to considering OTC devices.

It's also important to have realistic expectations regarding the capabilities of hearing aids. To ensure that OTC hearing aids are a suitable option for you, it is advisable to undergo a hearing test that confirms the type of hearing loss you have.

By keeping these factors in mind and staying informed about the advancements and considerations surrounding OTC hearing aids, individuals with mild to moderate hearing loss can make informed decisions about their hearing health.

William H. McDaniel, MD

Dr. Robert H. Shmerling is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center (BIDMC), and is a current member of the corresponding faculty in medicine at Harvard Medical School.

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