FDA-Device2026-03-11Class II
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Advanced Bionics, LLC
Hazard
Behind-the-ear sound processer packaging label is different then included product.
Sold states
Unknown
Affected count
2 units
Manufactured in
28515 Westinghouse Pl, N/A, Valencia, CA, United States
Products
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1493-2026Original summary
Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150 Behind-the-ear sound processer packaging label is different then included product. Lot Code: UDI-DI: 08400944CI5295YJ Model Number: CI-5295-150 Serial Numbers: 249596, 249603 Distribution: Unknown Affected quantity: 2 units
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