Category 1 Medical Devices: Impact of OTC Hearing Aids for Children

When your child experiences a complication involving hearing loss, it is important to consider all options for improving your child's hearing capacity. For many hearing impaired children, the use of hearing aids is quite common and is quite successful in bridging the gap that hearing loss creates. When shopping for a hearing aid for your child, it is important to remember there are many options on the market today and it is important to also never settle for what seems to be most cost effective at initial glance.

Hearing aids and hearing devices for children are generally classified by the FDA as Category 1 medical devices however there are some that are classified much higher. This means a hearing aid in Category 1 poses the lowest safety risk to your child and is often the device used and recommended by a pediatric audiologist. However, a Category 1 medical device hearing aid may not be what your child truly needs. If you are struggling with the cost associated with hearing aids, the Category 1 device may be your best option.

Even over-the-counter hearing aids are classified as Category 1 medical devices. More commonly referred to as hearing amplification devices, parents will opt to use this lower cost option especially when health insurance may not cover the cost of a more advanced form of hearing aid device. However, it is important to remember that even though these over-the-counter hearing aid devices are cheaper, they may pose a greater health risk to your child and even lead to further loss of hearing. For this reason, many audiologists will not recommend the use of OTC hearing aids and there is even a growing push to request that the FDA classify over-the-counter hearing aids differently than prescribed hearing aid devices.

When considering the cost, benefits, risks and disadvantages to a Category 1 medical device, it is important to ask the pediatric audiologist about the costs and long term health benefits associated with special purpose hearing aids versus conventional hearing aids. In other words, even if your audiologist has prescribed a Category 1 hearing aid, purchasing one over the counter may not provide the hearing services you may need and, instead, you may require a more specialized form of hearing device. Until the categorization of OTC hearing aids is changed, there may be great confusion in finding the right hearing aid device for your child, whether over-the-counter or prescription, for your child.