Tech, Law, and Hearing Aids

(by Will Kaufman, Colorado Law 2L)

People tinkering with and modifying their electronic devices is becoming more and more common in America. This trend, which has seen people seeking greater access to their cars and cell phones, has recently been expanding into more unexpected areas of personal electronics. One particular focus for tinkerers are their hearing aids.

As hearing aid use becomes more common and the average consumer becomes more tech savvy, the interest in tinkering with hearing aids has expanded. There are a variety of reasons why people are interested in tinkering with hearing aids. The most common reasons are to gain the ability to adjust a hearing aid without having visit an audiologist and to modify hearing aid technology to provide new and expanded features.

However, hearing aids are medical devices regulated by the FDA. Moreover, the United States government is not the only body with an interest in regulating hearing aids; almost every state currently regulates the sale, repair, and adjustment of hearing aids.

State laws regulating hearing aids come in a variety of forms but generally share common themes rooted in consumer protection and public health. With few exceptions, most states have laws regulating the dispensing of hearing aids. In order to sell hearing aids, dispensers must first be licensed by the state. Many states have strict laws regarding hearing aid warranties and pricing schemes. For example, Florida law provides consumers with a 30-day risk-free trial periods for their hearing aids. By requiring dealers to be licensed, Florida is able to ensure that hearing aid dispensers are aware of the 30-day risk-free trial period and that consumer rights are protected.

Additionally, some states have restrictions on who can repair hearing aids. Law restricting the repair of hearings are enacted in order to ensure that people advertising themselves offering hearing aid repair have the skills to perform these skill. These laws provide consumer protection and help ensure that consumers will not be physically harmed by a faulty repair job.

The last and least common type of state laws regarding hearing aids deal with the adjustment of hearing aids. While the repair of hearing aids includes the reprograming of the device and possible replacement of parts, adjusting hearing aids generally involves changing the settings. States that regulate the adjustment of hearing aids require individuals to first be licensed before they can make adjustment to hearing aid settings. Like regulating repair, states regulate adjustment to ensure that consumers a protected from individuals not qualified to perform the services they are advertising.

Adjustment laws however, are in a direct conflict with people who want to tinker with their hearing aids. While adjustment laws were enacted in order to ensure that people adjusting hearing do not harm the user of the devices, it is unclear how there laws will be applied to individuals seeking to adjust their own hearing aid.  While individuals are generally not exempt from adjusting their own hearing aids under these laws, these laws were not enacted specifically to prevent individuals from making adjustments themselves.

The consequences of violating the laws however, may be severe. For instance, North Carolina law defines the scope of practice of a hearing aid specialists to includes performing hearing aid fittings, programming, and adjustments. This law makes it a class two misdemeanor for anyone within the state of North Carolina to engage within the scope of practice of a hearing aids specialist without first being licensed. Florida law makes selling a hearing aid without a license a third degree felony.

While the intent of these laws was to protect the public advancements in technology and a new wave of tech-savvy hearing aid users may lead some state legislatures to revisit them. Otherwise, these laws may stymie the development of technologies that will make it easier for people to access and adjust their hearing aids or impose criminal liability on people who tinker with their hearing aids.