An “over-the-counter” hearing aid can put treatment within reach


Yi Hu has a prototype of the hearing aid he developed for the over-the-counter hearing aid market. The FDA is expected to issue guidelines for approving OTC devices soon. (UWM Photo/Elora Hennessey)

Yi Hu was always close to his grandfather, who lived in a poor, mining region of China. Around 2005, her grandfather began to complain of hearing difficulties.

“We knew hearing aids could help him, but living in a small town, he didn’t have access to audiologists, and the hearing aids were just too expensive for him,” said Hu, an associate professor of engineering. Electrical at the University of Wisconsin. Milwaukee.

His grandfather’s dilemma is common. According to the National Institute of Deafness and Other Communication Disorders, only one in six people in the United States who could benefit from hearing aids use them. The reason is mainly the cost. Basic health insurance does not cover hearing aids, a situation that has caused hearing health inequities for low-income and rural residents.

Untreated hearing loss can be serious as it is associated with dementia, depression, falls and social isolation.

Hu’s prototype undergoes more modifications to reduce its size, which is difficult to accomplish without losing performance. (Photo courtesy of Yi Hu)

Hu designed a prototype device that, when paired with a smartphone app, approximates the experience of an audiologist. He envisions consumers with mild to moderate hearing loss being able to buy a hearing aid over-the-counter, much like you can buy reading glasses at the drugstore without a prescription.

Since Hu’s technology doesn’t require fitting by an audiologist like traditional hearing aids do, it could drop the cost of quality hearing loss treatment from thousands to hundreds of dollars.

Through his start-up, My Hearing Care, established in 2017, he plans to launch his device on the mass market in 2023.

“If widely adopted, it will revolutionize the hearing industry,” Hu said.

Federal approval for over-the-counter aids expected soon

The market for over-the-counter hearing aids will open wide once the Federal Drug Administration releases guidelines for them, which should happen soon.

There are already devices on the market called Personal Sound Amplification Products, or PSAPs, and some of them have settings controlled by smartphone apps.

But the Food and Drug Administration does not allow advertising of PSAPs as a treatment for hearing loss. Without an FDA approval process, consumers have no way of knowing which products are effective and which are undesirable.

Hu’s current prototype looks more like an entry-level hearing aid than a PSAP. Users can not only adjust their devices using an app on their smartphone, but they can also perform their own basic hearing test to obtain an audiogram, the same process audiologists use to prescribe traditional hearing aids.

An audiogram is a measurement of the quietest sounds a person can hear at different pitches or frequencies. With audiogram data, users can find the settings that match their hearing needs in different environments.

how people hear

To understand how unusual Hu’s prototype is, you first need to know some basics about how people hear. When sound waves enter the ear, they vibrate the eardrum and middle ear bones. Tiny ‘hair’ cells inside the cochlea – part of the inner ear – convert these vibrations into neural signals that are transmitted to the brain via the auditory nerve.

To improve hearing, a device usually needs to do more than just turn up the volume. Hearing assessment also involves sound wave frequencies – how fast sound waves vibrate. This is equivalent to the pitch we hear perceived as high or low.

People have different sensitivity to sounds at different frequencies. Ordering in a drive-thru and watching TV at home will involve a mix of very different frequencies. And each frequency will be amplified differently.

When hearing is impaired, it becomes more difficult to hear certain sounds in the wide frequency range of normal conversation. Consonants, for example, are often in the upper frequency range of 2,000 to 8,000 hertz. As you get older, many lose perception of the higher end of the range.

Ability to customize settings

Hu’s device not only allows the user to accurately test their own hearing, but it also allows them to customize their settings to suit their needs in each new environment and then save the setting.

There is complexity in science. For example, a person’s audiogram may show that their hearing is within the normal range, yet they still have difficulty hearing in certain situations.

The ability to customize your settings is limited or not available in current PSAPs that have just been introduced to the market, Hu said.

“Only you know what you can hear,” he said. “So unless we allow users to personally tune the device, it’s not going to be an individualized solution.”


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