Table 1. FDA-approved Labeling for Adults for Current Cochlear Implant Systems.
Device | Audiometric indications | Speech recognition indications |
---|---|---|
Advanced Bionics HR90K Ultra 3D | Severe to profound, bilateral sensorineural hearing loss (>70 dB HL) | ≤50% for open-set sentence recognition (HINT sentences) |
Cochlear Profile and Profile Plus | Moderate to profound hearing loss in the low frequencies and profound (≥ 90 dB HL) hearing loss in the mid to high frequencies | ≤50% in the ear to be implanted (≤60% in the best-aided condition) on recorded tests of open-set sentence recognition |
Cochlear Hybrid—L24 | Thresholds ≤ 60 dB HL through 500 Hz and ≥70 dB HL for 2,000 Hz + | ≤60% CNC word recognition in the ear to be implanted, ≤80% CNC in contralateral ear |
MED-EL Synchrony and Synchrony 2 | Bilateral severe to profound sensorineural hearing loss (pure tone average ≥ 70 dB HL) | ≤40% in best-aided listening condition on recorded tests of open-set sentence recognition (HINT sentences) |
MED-EL Synchrony and Synchrony 2 EAS | Thresholds ≤65 dB HL through 500 Hz and ≥ 70 dB HL for 2,000+ | ≤60% CNC word recognition in the ear to be implanted and in the contralateral ear |
MED-EL Synchrony and Synchrony 2 for single-side deafness | Thresholds ≥90 dB HL in the ear to be implanted and normal hearing or mild sensorineural hearing loss in the other ear | <5% CNC word recognition in the ear to be implanted |
MED-EL Synchrony and Synchrony 2 for asymmetric hearing loss | Thresholds ≥90 dB HL in the ear to be implanted and mild to moderately severe sensorineural hearing loss in the other ear, with a difference of at least 15 dB in pure tone averages between ears | <5% CNC word recognition in the ear to be implanted |
Oticon Neuro System | Severe to profound hearing loss (pure tone average ≥ 70 dB HL at 500, 1,000, and 2,000 Hz) | 50% or less on HINT sentences in quiet or noise, in the best-aided listening condition |
Abbreviations: CNC, Consonant–Nucleus–Consonant; HINT, hearing in noise test.
Source: Adapted from Gifford et al. 9