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. 2021 Dec 9;42(4):331–341. doi: 10.1055/s-0041-1739283

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