About OTCs, PSAPs, and Hearables

Supporting Affordable Solutions

In 2015, the President’s Council of Advisors on Science and Technology (PCAST) reviewed age-related hearing loss and barriers to technologies that might improve and enhance their lives. A panel of 19 academic scientists and industry leaders advising President Obama reviewed the problem and identified cost as the key barrier to ownership.

Audiologists were supportive of addressing cost concerns, but felt that the PCAST members had ignored other important data from countries such as Great Britain where the National Health Service provides hearing aids at no cost as a part of their health plans. Even where hearing aids are given to residents who need them, the number of people who obtain help for their hearing is not any higher than the use reported in the U.S. On average, people wait 7-10 years before getting help (1).

A longitudinal study in the U.S. studied people with hearing loss who had not obtained hearing aids (2). They found three barriers:

• Perception that they did not have a problem and therefore did not need a hearing aid,

• They knew of someone who had a negative experience with a hearing aid, and

• Cost

The PCAST members of the advisory board did not understand how much the social stigma associated with hearing loss and use of hearing aids influenced the decision to acquire or purchase them.

In August 18, 2017, President Trump signed the OTC Hearing Aid Act requiring the FDA to create and regulated over-the-counter hearing aids for adults with perceived hearing loss. The FDA was charged with developing regulations to make sure that the OTC devices met the same standards for consumer safety, labeling, and manufacturing that other medical devices must meet.

The FDA has a backlog of issues requiring their attention including response to the COVID-19 epidemic. While the legislation included a provision that the OTC category be established by August 18, 2020, it is not uncommon for the timeline to change. In addition to the Federal guidelines, States differ in their hearing aid dispensing laws and rules for both traditional and online sales of hearing instruments. Here is a link to the Federal government website to keep up on the status of the latest OTC legislation:

https://www.nidcd.nih.gov/health/over-counter-hearing-aids

While most insurance plans do not cover the costs of hearing aids, eyeglasses, and dental work, there is an interest on the part of consumers in affordable solutions to hear, see, and chew. Most consumers need professional care as a component of affordable equipment and want to receive a good value for the money they spend.

Companies who sell Over-the-Counter (OTC), Personal Sound Amplification Products (PSAP), and Hearables are interested in selling the greatest number of units. They send the message to the consumer that they just need a widget to make sound louder to solve their hearing problems.

Audiologists know that solving hearing loss problems is not about making sound louder. Our detailed histories allow us to understand factors that may have caused the hearing loss. The diagnostic testing provides an understanding of the degree and type of hearing loss including loss of structures in the ear and how that will affect speech understanding. We want to help our patients find solutions to the loss of sound clarity. We look at the whole patient before making a recommendation for a type or product or service to factor in variables such as loss of auditory memory, decrease in ability to follow timing cues that provide spatial information, increased tinnitus, difficulty understanding soft elements of speech and understanding speech in noise. We look at challenges that affect everyday communication on the phone, hearing from another room, understanding TV, hearing in large rooms such as a church, theater, or auditorium. We want to make sure that if the baby or grandchild is crying in another room that we know and can respond and that beloved sounds of nature are audible. Finally, audiologists can help you find not only devices, but communication strategies to help you and others communicate more effectively so you can enjoy life. These professional services are not found in a box in a store.

So, if you need an affordable solution, let your audiologist know. They will help you find the right solution to meet your specific hearing needs at a price you can afford.

References:

1. Blustein J, Weinstein BE. Opening the Market for Lower Cost Hearing Aids: Regulatory Change Can Improve the Health of Older Americans. Am J Public Health. 2016;106(6):1032‐1035. doi:10.2105/AJPH.2016.303176

2. Fischer ME, Cruickshanks KJ, Wiley TL, Klein BE, Klein R, Tweed TS. Determinants of hearing aid acquisition in older adults. Am J Public Health. 2011 Aug; 101(8):1449-55.

Buying a Hearing Aid over the counter (OTC)

One study (Tredeschi and Kihm, Hearing Review, March 2017) wanted to determine if individuals could:

• Self-diagnose the presence of a mild or moderate hearing loss without undergoing any formal hearing evaluation?

• Self-identify the need for medical evaluation?

• Self-select and self-manage an effective treatment option or product?

Findings

• Thirteen percent were not able to correctly self-assess the degree of their hearing loss or to determine if their hearing loss was in one ear or both ears.  1 in 10 who reported a mild or moderate loss had normal hearing.

• While participants were familiar with basic elements of choosing a device such as style, price, and battery life, they were not as knowledgeable about technical features. 1 in 5 selected devices with outputs higher than 120 (harmful).

• At the end of six weeks, less than half were satisfied with their devices.

Risks of missing medical problems

PSAPs (Personal Sound Amplifiers)

Hearing Loss is not just a loss of volume

• Difficulty hearing soft speech

• Loss of structure in the ear results in a loss of the ability to separate sounds

• Difficulty in understanding speech in noise

• Loss of timing cues that provide spatial information

• Increased awareness of tinnitus

Many PSAPs produce dangerous sound levels

Hearables

Definition: Any technology or group of technologies that work in combination with each other to enhance hearing ability.

• Listening to music

• Wireless smartphone access

• Voice recognition access to the internet.

Benefits:

• Reduces reliance on seeing handheld screens

• Provides personal assistant

• Connects with Wearables to collect biometric data.