OTC de­vices hold their own against costly hear­ing aids

Walker County Messenger - - Front Page - By Michelle An­drews

Hear­ing aids that can cost more than $2,000 apiece are only slightly more ef­fec­tive than some over-the­counter sound-am­pli­fi­ca­tion de­vices that sell for just a few hun­dred dol­lars, ac­cord­ing to a re­cent study.

The study bol­sters leg­is­la­tion pend­ing in Congress, which would have the Food and Drug Ad­min­is­tra­tion set reg­u­la­tions for cheaper over-the-counter prod­ucts and is de­signed to make the de­vices more widely ac­ces­si­ble and safer. Con­sumers with mild to mod­er­ate hear­ing loss would be able to pur­chase the de­vices with­out a pre­scrip­tion and with­out a med­i­cal exam, know­ing they meet fed­eral safety stan­dards.

For the study, re­searchers com­pared how well 42 older adults with mild to mod­er­ate hear­ing loss re­peated sen­tences spo­ken in the pres­ence of back­ground noise. The re­searchers first tested their abil­ity to un­der­stand the speaker with­out any de­vices. Then they tested the sub­jects suc­ces­sively with a hear­ing aid and with five “per­sonal sound am­pli­fi­ca­tion prod­ucts” sold over the counter.

The hear­ing aid used in the study was a brand com­monly dis­pensed in au­di­ol­ogy clin­ics. The per­sonal sound am­pli­fi­ca­tion prod­ucts (PSAPs) that were se­lected ei­ther had the best elec­troa­cous­tic prop­er­ties or were com­monly avail­able in re­tail phar­ma­cies. PSAPs per­form like hear­ing aids but can’t be mar­keted as hear­ing aids be­cause they don’t meet stan­dards set by the FDA.

The re­sults, pub­lished this month in JAMA, found very lit­tle dif­fer­ence be­tween the hear­ing aid, which costs about $1,900 per ear, and some of the PSAPs, which mostly cost be­tween $300 and $350 each.

On av­er­age, study par­tic­i­pants were able to ac­cu­rately re­peat about three-quar­ters of the words spo­ken to them with­out us­ing any de­vice. Us­ing the hear­ing aid boosted their un­der­stand­ing to an av­er­age 88.4 per­cent. And four out of the five PSAPs were nearly as ef­fec­tive as the hear­ing aid, with av­er­age word un­der­stand­ing rang­ing from 81.4 per­cent to 87.4 per­cent. The fifth PSAP per­formed poorly: Peo­ple could hear bet­ter with their naked ears.

Age-re­lated hear­ing loss is a com­mon prob­lem, but only about a quar­ter of the roughly 30 mil­lion peo­ple who have it use hear­ing aids, said Nicholas Reed, an au­di­ol­ogy in­struc­tor at Johns Hop­kins School of Medicine who was the study’s lead au­thor.

“That’s a lot of peo­ple who aren’t get­ting in through the door,” he said.

Cost is a de­cid­ing fac­tor for many con­sumers. Medi­care doesn’t cover hear­ing aids, nor do most pri­vate health in­sur­ance plans.

Iden­ti­cal ver­sions of the bi­par­ti­san Over-the-Counter Hear­ing Act of 2017 were in­tro­duced in the House and Se­nate this year. The text of those bills has been added as an amend­ment to the FDA Reau­tho­riza­tion Act of 2017, a bill that is key to FDA op­er­a­tions be­cause it sets the gov­ern­ment’s sys­tem for col­lect­ing fees dur­ing the drug ap­proval process.

Not sur­pris­ingly, hear­ing aid man­u­fac­tur­ers and distrib­u­tors are against the bill. So are gun own­ers, who claim that reg­u­lat­ing hear­ing am­pli­fiers, which some hunters use to de­tect game, is in ef­fect a way to reg­u­late hunt­ing and un­der­mine their Se­cond Amend­ment rights.

Reed said that by re­quir­ing the FDA to is­sue reg­u­la­tions on over-the­counter hear­ing aids, the pro­posed amend­ment would im­prove the prod­ucts sold. Many of them, he said, are not ef­fec­tive and some are dan­ger­ous be­cause there’s no con­trol over am­pli­fi­ca­tion lev­els.

“When it gets to a cer­tain am­pli­fi­ca­tion, it will just blow your hear­ing out,” he said. “Over-the­counter hear­ing mea­sures would reg­u­late these de­vices and force them to meet stan­dards.”

KHN’s cov­er­age re­lated to ag­ing & im­prov­ing care of older adults is sup­ported by The John A. Hart­ford Foun­da­tion.

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