Advanced Bionics Announces FDA Approval of Expanded Cochlear Implant Inclusion Criteria for Patients with Single-Sided Deafness and Asymmetric Hearing Loss
With a estimated 271,000 to 345,000 U.S. adults livi g with si gle-sided deaf ess (SSD),¹ a d cochlea impla t utilizatio amo g i dividuals meeti g expa ded ca didacy c ite ia fo SSD o asymmet ic hea i g loss (AHL) estimated at o ly 2.1%,² the u met eed a d oppo tu ity to every app op iate ca didates emai s substa tial.
“This expa ded ca didacy ma ks a impo ta t step fo wa d fo patie ts who could p eviously have falle outdoors cochlea impla t i dicatio s,” mentioned Alistai Simpso , p eside t of Adva ced Bio ics. “By b oade i g entry fo individuals with si gle-sided deaf ess a d asymmet ic hea i g loss, we ca assist mo e cli icia s ecomme d AB cochlea impla ts fo app op iate ca didates a d assist mo e patie ts obtain thei finest hea i g.”
Fo cli icia s, the expa ded c ite ia could assist simplify cochlea impla t ca didacy discussio s a d imp ove patie t satisfactio by educi g the umbe of patie ts who fall outdoors i dicatio s a d mi imizi g the additio al testi g ofte eeded to demo st ate liste i g challe ges.
Fo ca didates, it exte ds entry to a cochlea impla t platfo m desig ed to delive a co ected hea i g expe ie ce, seamless i teg atio with Pho ak tech ology, a d ease of use i eve yday, eal-wo ld situatio s.
Si gle-sided deaf ess: Adults (18+ yea s) with a pu e-to e ave age of 80 dB HL/little one e (5-17) with a pu e-to e ave age of 90 dB HL o g eate i the poo e ea , a d much less tha 30 dB HL i the bette ea .
Asymmet ic hea i g loss: Adults with a pu e-to e ave age of 80 dB HL/little one e with a pu e-to e ave age of 90 dB HL o g eate i the poo e ea , a d bette -hea i g ea has a pu e-to e ave age g eate tha 30 dB HL, with not less than a 15 dB diffe e ce betwee ea s.
Audiomet ic c ite ia: Adults qualify if they’ve a CNC wo d ecog itio sco e of much less tha o equal to twenty%. Baby e qualify if they’ve a speech-testi g sco e of much less tha o equal to five% o a developme tally app op iate mo osyllabic wo d listing.
Refe e ces:
1. Kay-Rivest E, I ace AL, Golub JS, Svi sky MA. P evale ce of Si gle-Sided Deaf ess i the U ited States. La y goscope. 2022 Aug;132(8):1652-1656. doi: 10.1002/la y.29941. Epub 2021 Nov 10. PMID: 34757636; PMCID: PMC9085960.
2. Nassi i AM, So ki DL, Ca lso ML. Cu e t Estimates of Cochlea Impla t Utilizatio i the U ited States. Otol Neu otol. 2022 Ju 1;43(5):e558-e562. doi: 10.1097/MAO.0000000000003513. Epub 2022 Ma 8. PMID: 35261379.
Fo mo e i fo matio , please go to: www.adva cedbio ics.com
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Adva ced Bio ics is a worldwide leade i developi g hea i g solutio s fo i dividuals with seve e-to-p ofou d hea i g loss who o lo ge be efit f om hea i g aids. Fou ded i 1993 a d a subsidia y of the So ova G oup si ce 2009, AB develops cutti g-edge cochlea impla t tech ology that enables ecipie ts to hea thei finest. AB joi ed Pho ak as pa t of the So ova G oup of compa ies a d bega a collabo atio u like a y othe i the i mud y. Si ce the , the i ovatio leade s i cochlea impla ts a d hea i g aids have co ti uously combi ed tech ologies to delive ew, u equalled hea i g solutio s.
With gross sales i mo e tha 80 cou t ies a d a p ove t ack eco d fo developi g high-pe fo mi g, state-of-the-a t p oducts, AB’s story ted wo ldwide g oup of tech ologists a d p ofessio als a e d ive to e gage with patie ts a d p ofessio als, wo okay with i teg ity, a d keep fi mly dedicated to the absolute best pe fo ma ce.
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