Dr. Gantz emphasized that basic questions about OTC devices, such as whether patients will need to visit an audiologist or otolaryngologist and who will fit the devices, remain unanswered.
One clear shared concern among otolaryngologists and audiologist is the safety of offering OTC hearing aids without a clinical examination and diagnosis. “The main concerns expressed to date by the AAO–HNS center around patient inexperience in navigating a new system that could lead to inaccurate diagnoses and inappropriate use of hearing aids,” said Dr. Denneny.
Until specifics of the law are known there is little information on how the devices will be fitted. Dr. Denneny said that ill-fitting hearing aids can cause irritation and possible damage to the external auditory canal and even the ear drum. “Along with significant discomfort, improperly fitted hearing aids also cause ‘squealing’ sounds that discourage regular usage,” he added.
Another safety concern raised by Mann is the potential use of OTC hearing aids in children. Although the law is centered on providing OTC hearing aids for patients at least 18 years of age, she worries that parents may purchase them for their children. “That’s a great concern, given the importance of access to speech sounds during development and a host of potential issues that could arise when it comes to children,” she said. She added that it will be important to ensure that specifications for the devices be tailored only for adults and for mild hearing loss.
Dr. Denneny also emphasized that OTC hearing aids are not appropriate for children. “The AAO–HNS feels it is essential that pediatric patients have access to complete examination, accurate diagnoses, and proper fitting of the appropriate medical device for their type of hearing loss,” he said. “The consequences of not identifying and treating hearing loss in the pediatric patient have a negative impact that often lasts throughout their lifetime.”
Opportunity for Education
The FDA is taxed with providing details of this new law over the next three years. Until then, Mann said that passage of the law is an important first step to starting the conversation on the importance of hearing loss and barriers to access. “We’ve long known the typical delay from hearing loss identification to intervention can be upward of seven years,” she said. “This is an opportunity to start thinking about hearing loss sooner.”
Mann also thinks that the law opens up an even greater opportunity for audiologists to participate in the care of patients with hearing loss. “The audiologist is an important part of the process, since we have the knowledge and capacity to help patients safely select OTC hearing aids, orient them to their use and care, and troubleshoot when something goes wrong,” she said.