The FDA re­con­sid­ers the rules on hear­ing aids

The White House wants looser rules on over-the-counter sales Reg­u­la­tions are “un­fair to us and to con­sumers who might ben­e­fit”

Bloomberg Businessweek (Asia) - - CONTENTS - Paul M. Barrett The bot­tom line The White House sug­gests open­ing up the $5 bil­lion mar­ket for hear­ing aids to more over-the-counter de­vices.

The Bean is a small elec­tronic de­vice that peo­ple can put in their ears to help them hear bet­ter. Like hear­ing aids, it au­to­mat­i­cally am­pli­fies soft sounds and lets loud ones be heard nat­u­rally. Un­like hear­ing aids, which are reg­u­lated by the U.S. Food and Drug Ad­min­is­tra­tion and can be sold only by li­censed hear­ing ex­perts, the Bean is avail­able over the counter. The cheap­est model re­tails for $299, a lit­tle more than one-tenth the price of most pre­scrip­tion hear­ing aids. But FDA guide­lines pro­hibit Bean man­u­fac­turer Ety­motic Re­search from mar­ket­ing it to peo­ple who are hard of hear­ing. “We’re limited in how we can sell the Bean, and that’s un­fair to us and to con­sumers who might ben­e­fit from it,” says Ety­motic Pres­i­dent Mead Killion, a Ph.D. in audiology who holds 90 patents.

In Oc­to­ber a sci­en­tific panel con­vened by the White House sug­gested

loos­en­ing reg­u­la­tions on hear­ing aids to en­cour­age the pro­lif­er­a­tion of low­er­cost op­tions such as Killion’s. The logic seems straight­for­ward—drug­stores sell low-power read­ing glasses over the counter, so why not “per­sonal sound am­pli­fi­ca­tion prod­ucts,” or PSAPs, like the Bean? The FDA ap­par­ently got the mes­sage: On April 21 it was sched­uled to hold a pub­lic work­shop on whether its man­u­fac­tur­ing stan­dards for hear­ing aids are overly re­stric­tive. The agency, which has ul­ti­mate au­thor­ity to set reg­u­la­tions, is de­ter­mined “to bet­ter un­der­stand how we can over­come the bar­ri­ers to ac­cess and spur de­vel­op­ment of de­vices that com­pen­sate for im­paired hear­ing,” Wil­liam Maisel, act­ing di­rec­tor of the FDA’s Of­fice of De­vice Eval­u­a­tion, said in an e-mail.

Killion will be at the hear­ing, as will rep­re­sen­ta­tives of the White House panel. So will rep­re­sen­ta­tives of the Big Six hear­ing aid man­u­fac­tur­ers— Siemens, Sonova, Starkey Hear­ing Tech­nolo­gies, Wil­liam De­mant, GN

Re­Sound, and Widex—which con­trol up­wards of 95 per­cent of the $5 bil­lion global mar­ket and en­dorse the FDA’s cur­rent hard line on PSAPs.

The old-school man­u­fac­tur­ers, un­sur­pris­ingly, wish to marginal­ize PSAPs as a so­lu­tion for hear­ing loss. Un­der ex­ist­ing FDA rules, the de­vices can be sold only for recre­ational use, tar­get­ing peo­ple with nor­mal hear­ing (think hunters lis­ten­ing for prey, or bird­ers track­ing rare breeds by their chirps). “If they worked, most peo­ple would be us­ing them,” says Ca­role Ro­gin, pres­i­dent of the Hear­ing In­dus­tries As­so­ci­a­tion, a trade group. She says the White House panel, which is made up of aca­demics and busi­ness ex­ec­u­tives— in­clud­ing Eric Sch­midt, ex­ec­u­tive chair­man of Al­pha­bet, the hold­ing com­pany for Google—is ap­proach­ing the prob­lem of un­der­treated hear­ing loss the wrong way. “There is no ev­i­dence that con­sumers can self-di­ag­nose and self-treat,” Ro­gin says. “You run the risk of se­ri­ous med­i­cal con­di­tions go­ing un­ad­dressed.”

Only 15 per­cent to 30 per­cent of the roughly 30 mil­lion Amer­i­cans with hear­ing loss seek help, ac­cord­ing to the White House panel’s re­port, which also as­serted that the high cost of med­i­cal hear­ing aids is the big­gest rea­son the num­ber is so low. Con­ven­tional hear­ing aids sell for more than $2,300 apiece on av­er­age, and many peo­ple need one for each ear. Medi­care and most pri­vate in­surance plans don’t cover hear­ing aids. And over­lap­ping fed­eral and state reg­u­la­tions have helped sti­fle com­pe­ti­tion in the in­dus­try. The FDA and states re­quire that con­sumers ob­tain a med­i­cal eval­u­a­tion and then pur­chase hear­ing aids from a li­censed au­di­ol­o­gist or other cre­den­tialed dis­penser. Prac­ti­tion­ers typ­i­cally of­fer a limited se­lec­tion of brands and charge a sin­gle, bun­dled fee for the eval­u­a­tion, the hear­ing aid, and any fol­low-up ad­just­ments.

The FDA has cracked down on PSAP man­u­fac­tur­ers that com­pare their over-the­counter gear to hear­ing aids. Fed­eral agents seized a ship­ment from China of Neu­tron­icEar de­vices in June 2014 be­cause on­line ads for the prod­uct in­cluded cus­tomer tes­ti­mo­ni­als say­ing the de­vice is equiv­a­lent to “a reg­u­lar hear­ing aid.” Brian Brinker, di­rec­tor of oper­a­tions for Per­sonal In­no­va­tive Prod­ucts, the com­pany that mar­kets Neu­tron­icEar gear, says: “We got rid of the lan­guage the FDA didn’t like, and they re­leased our ship­ment.”

The White House panel pointed out that the tech­nol­ogy in PSAPs is of­ten “sim­i­lar, if not iden­ti­cal, to that in hear­ing aids.” It urged the FDA to cre­ate a new cat­e­gory of “ba­sic” hear­ing aids that would be reg­is­tered with the agency but sold over the counter, with­out any re­quire­ment to

visit a spe­cial­ist. “For peo­ple with mild to mod­er­ate hear­ing loss, this could be a way to try some­thing out and see if it helps them,” says Chris­tine Cas­sel, a mem­ber of the White House panel and the plan­ning dean at the newly es­tab­lished Kaiser Per­ma­nente School of Medicine in Pasadena, Calif. “I’ve tried them, and some of th­ese new gad­gets are very help­ful.”

At least some groups rep­re­sent­ing in­di­vid­u­als with im­paired hear­ing agree with the push for more ex­per­i­men­ta­tion. Hear­ing Loss As­so­ci­a­tion of Amer­ica Ex­ec­u­tive Di­rec­tor Bar­bara Kel­ley says that at the April 21 hear­ing her or­ga­ni­za­tion in­tends to en­cour­age the FDA to con­sider the White House panel rec­om­men­da­tions, which are “an im­por­tant step in rais­ing pub­lic aware­ness around the is­sues of hear­ing loss, ex­pand­ing consumer choice, and driv­ing change in the mar­ket­place.”

Ety­motic’s Bean in-ear am­pli­fier is avail­able over the counter, un­like hear­ing aids

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