FDA.reportPublic FDA data

PMA P960058S167

Device
HiResolution™ Bionic Ear System
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S167
Product code
MCM
Decision date
2026-07-22
Classification
Ear, Nose, Throat
Generic name
Implant, cochlear
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.

Current openFDA PMA Record#

Device
HiResolution™ Bionic Ear System
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S167
Product code
MCM
Generic name
Implant, cochlear
Decision date
2026-07-22
Decision code
APPR
Date received
2025-01-29
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
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.