Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHiResolution™ Bionic Ear System
Generic NameImplant, cochlear
ApplicantAdvanced Bionics
28515 Westinghouse Pl.
Valencia, CA 91355
PMA NumberP960058
Supplement NumberS167
Date Received01/29/2025
Decision Date07/22/2026
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Unilateral Hearing Loss The HiResolution™ Bionic Ear System is indicated for individuals with unilateral hearing loss who meet the following criteria: Asymmetric Hearing Loss (AHL) Individuals with AHL are defined as those with a mild to moderately severe hearing loss in the better ear, i.e., a 4PTA of 31 to 65 dB HL at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz, with a difference of at least 15 dB in the 4PTA between ears. It is recommended that individuals with AHL have at least two (2) weeks experience wearing an appropriately fitted Contralateral Routing of Signal (CROS) system or suitable hearing device prior to cochlear implantation. The ear to be implanted will be as follows: Adults (18 years of age or older): Severe to profound sensorineural hearing loss (4PTA of 500, 1000, 2000, and 4000 Hz = 80 dB HL) A score of = 20% on a Consonant-Nucleus-Consonant (CNC) word test Children (5 years through 17 years of age): Profound sensorineural hearing loss (4PTA of 500, 1000, 2000, and 4000 Hz = 90 dB HL) Insufficient functional access to sound in the ear to be implanted must be determined by aided speech perception test scores of 5% or less on a developmentally appropriate monosyllabic word list when tested in the ear to be implanted alone. Single-Sided Deafness (SSD) Individuals with SSD are defined as those with normal hearing or mild sensorineural hearing loss in the better ear (4PTA of = 30 dB HL at 500, 1000, 2000, and 4000 Hz). It is recommended that individuals with SSD have at least two (2) weeks experience wearing an appropriately fitted Contralateral Routing of Signal (CROS) system or suitable hearing device prior to cochlear implantation. The ear to be implanted will be as follows: Adults (18 years of age or older): Severe to profound sensorineural hearing loss (4PTA of 500, 1000, 2000, and 4000 Hz = 80 dB HL) A score of = 20% on a Consonant-Nucleus-Consonant (CNC) word test Children (5 years through 17 years of age): Profound sensorineural hearing loss (4PTA of 500, 1000, 2000, and 4000 Hz = 90 dB HL) Insufficient functional access to sound in the ear to be implanted must be determined by aided speech perception test scores of 5% or less on a developmentally appropriate monosyllabic word list when tested in the ear to be implanted alone.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
-
-