In Rural Areas Where Audiologists are Rare, Telemedicine Can Help

In November, the FDA issued a ruling that will make life easier for cochlear implant recipients living in rural areas.

Implant surgery and immediate follow-up for mapping and programming must be done at a medical center or specialized clinic, but the new FDA ruling would allow remote programming for later adjustments. The audiologist and patient communicate via two-way video, with the audiologist programming the implant via computer just as he or she would in person.1495316546168 copy

The new ruling applies to Cochlear America’s Nucleus Cochlear Implant System, but other implant companies will probably follow with similar features. The ruling may eventually apply to programming hearing aids as well.

The FDA approved remote programming for patients age 12 and over who have had their implant for at least six months and who are comfortable with the programming process.

The FDA based its ruling on a clinical study of 39 patients, each of whom had had an implant for at least one year. The study included one in-person programming and two remote programming sessions for each patient. “Speech perception tests one month after each session showed no significant difference between in-person and remote programing,” the FDA said.

Twenty percent of Americans live in rural areas, while only nine percent of physicians practice there, according to an article by Greg Slabodkin in the online newsletter Health Data Management.

This comes to about 62 million Americans, for whom access to affordable healthcare is a major concern, according to an earlier article in Health Data Management. David Schmitz, M.D., president of the National Rural Health Association, testified to a congressional committee last July. He added that broadband providers must invest in the necessary technological infrastructure to make telemedicine possible.

Audiologists in rural areas are even rarer than physicians. Telemedical programming allows qualified audiologists to reach far more patients than they would ordinarily be able to do.

Speaking of the November FDA ruling, Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health, said that telemedicine can “reduce the burden to patients and their families, especially those who must travel great distances or need frequent adjustments.”  Cochlear implants need adjustments not only as the user’s hearing adjusts to the implant, but as new technology becomes available. Since programming is done via the external processor, telemedicine is an easy and appropriate tool.

 

 

 

Affordable Hearing Aids Just Got a Giant Step Closer

Decision Could Make Hearing Aids Available Over-the-Counter
– Getty Images

Buying hearing aids could soon become as easy as buying reading glasses.

In a surprise announcement yesterday, the Food and Drug Administration (FDA) said that, effective immediately, it would no longer require adults to get a medical evaluation before buying most hearing aids.

The agency  is also considering creating a category of over-the-counter hearing aids to encourage more “new, innovative, lower-cost products to millions of consumers,” the agency said in a prepared statement.

The announcement was made at a meeting of the National Academies of Sciences, Engineering and Medicine on hearing health care. Previous recommendations from this group, as well as from a White House advisory panel on science and technology, and consumer and some audiologist groups, had urged easing this restriction to make hearing aids more affordable and accessible.

The decision does not apply to those ages 18 and under, who still must have a medical evaluation before purchasing hearing aids. It also does not apply to bone-conduction hearing aids or to prescription-use hearing aids that are inserted deep in the ear canal.

Age-related hearing loss affects some 30 million Americans, affecting not only their work and social interactions but also their overall health and quality of life. For most, the hearing loss begins before the age of 60. The isolation and loneliness that can result from serious hearing loss have been linked to a higher risk of cognitive decline and dementia.

Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from wearing a hearing aid actually use one, the FDA noted. The high price of the devices — about $4,600 a set — has been a major barrier. Medicare and many private insurance plans don’t cover the cost of hearing aids, so most consumers are stuck paying for them out of pocket.

In addition, six companies manufacture nearly all the hearing aids sold, and only one is based in the U.S., a White House blog post about the FDA decision said.

The impact of the FDA’s move could open the hearing aid market to new companies and more competition.

The ruling was one of several recommended by the Hearing Loss Association of America and other consumer groups. HLAA Executive Director Barbara Kelley commented, “We applaud the FDA’s decision to remove this requirement and believe it is a step forward to remove barriers and make hearing health care for consumers more affordable and accessible.”

“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” said FDA Commissioner Robert Califf, M.D.

 

This post was first published on AARP Heath on December 8, 2016.

For more on hearing loss and hearing health:

shoutingwonthelpLiving Better jpegKatherine Bouton is the author of “Living Better With Hearing Loss: A Guide to Health, Happiness, Love, Sex, Work, Friends … and Hearing Aids,” and a memoir, “Shouting Won’t Help: Why I — and 50 Million Other Americans — Can’t Hear You”. Both available on Amazon.com.