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Home Press Release Accesswire

Advanced Bionics Announces FDA Approval of Expanded Cochlear Implant Inclusion Criteria for Patients with Single-Sided Deafness and Asymmetric Hearing Loss

July 28, 2026
in Accesswire, Web3
Reading Time: 6 mins read
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New FDA i clusio c ite ia expa ds ca didacy fo si gle-sided deaf ess. Fo patie ts with asymmet ic hea i g loss, this ew c ite ia ep ese ts the b oadest ca didacy a ge i the i dust y, helpi g mo e pote tial ca didates access Adva ced Bio ics cochlea impla t tech ology.

VALENCIA, CA / ACCESS Newswi e / July 28, 2026 / Adva ced Bio ics, a global leade i cochlea impla t tech ology a d a So ova b a d, today a ou ced expa ded U.S. Food a d D ug Admi ist atio i dicatio s fo its cochlea impla t systems, givi g mo e adult a d pediat ic patie ts with si gle-sided deaf ess o asymmet ic hea i g loss a clea e path to bette hea i g with cochlea impla tatio .

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 each 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 may p eviously have falle outside cochlea impla t i dicatio s,” said Alistai Simpso , p eside t of Adva ced Bio ics. “By b oade i g access fo people with si gle-sided deaf ess a d asymmet ic hea i g loss, we ca help mo e cli icia s ecomme d AB cochlea impla ts fo app op iate ca didates a d help mo e patie ts achieve thei best hea i g.”

Fo cli icia s, the expa ded c ite ia may help 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 outside 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 access 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.

Expa ded FDA ca didacy INCLUSION c ite ia

Si gle-sided deaf ess: Adults (18+ yea s) with a pu e-to e ave age of 80 dB HL/child 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 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/child 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 at least a 15 dB diffe e ce betwee ea s.

Audiomet ic c ite ia: Adults qualify if they have a CNC wo d ecog itio sco e of less tha o equal to 20%. Child e qualify if they have a speech-testi g sco e of less tha o equal to 5% o a developme tally app op iate mo osyllabic wo d list.

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 visit: www.adva cedbio ics.com

# # #

About Adva ced Bio ics

Adva ced Bio ics is a global 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 allows ecipie ts to hea thei best. 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 dust 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 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 tale 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 k with i teg ity, a d stay fi mly committed to the best possible pe fo ma ce.

Media Relatio s co tact:

Adva ced Bio ics LLC,Email: [email p otected]

SOURCE: Adva ced Bio ics LLC

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