Device labeling selection criteria and indications as stated by FDA or manufacturer (summarized per device):
Vibrant Soundbridge selection criteria: audiologic results consistent with moderate to severe sensorineural hearing loss; adults 18+; pure tone AC thresholds within device-specified ranges at 500-4000 Hz; word recognition score >=50% using recorded material; normal middle ear anatomy; psychologically suitable
From FDA labeling
Maxum Hearing Implant selection criteria: audiologic results consistent with moderate to severe sensorineural hearing loss; adults 18+; patients desiring an alternative to acoustic hearing device; prior experience with appropriately fit hearing aids recommended
From FDA labeling
BAHA / Bone-anchored general: BAHA indications: adults with external ear malformations or chronically draining ear, PTA hearing loss >=45 dB or inability/unwillingness to use air conduction hearing aid; children 5+ (clearance extension)PTA BC >=45 dB HL (per labeling)
From FDA clearance
BAHA bilateral implantation: Bilateral implantation criteria: moderate to severe bilateral symmetrical conductive hearing loss ( <10 dB average difference or <15 dB at individual frequencies at 500,1,2,4 kHz) or mixed loss with average BC thresholds better than 45 dB HL
From FDA labeling
BAHA for SSD: SSD indication: unilateral SNHL with normal hearing in contralateral ear; normal hearing defined as PTA AC <=20 dB at 0.5,1,2,3 kHz; alternative to AC CROS<= 20 dB HL (AC) contralateral
From FDA labeling
Otomag Alpha 1 / Sophono: conductive or mixed losses with PTA BC for indicated ear better than 45 dB HL; bilateral symmetry criteria (<10 dB average difference or <15 dB at individual frequencies); SSD PTA AC of hearing ear <=20 dB HL<= 45 dB HL (BC) for indicated ear; <=20 dB HL (AC) for normal hearing
From FDA labeling
Cochlear Baha Attract: PTA BC <=45 dB HL for BP100 processor; <=55 dB HL for BP1100 processor (0.5,1,2,3 kHz); patients aged 5+; bilateral when criteria met; SSD defined as PTA AC <=20 dB HL<=45 dB HL (BP100); <=55 dB HL (BP1100); <=20 dB HL (AC) contralateral
From FDA labeling
Bonebridge (MED-EL): Bonebridge indications: PTA BC <=45 dB HL (0.5,1,2,3 kHz); patients 12+; bilateral symmetric definitions (<10 dB average or <15 dB individual); SSD alternative to AC CROS with hearing ear PTA AC <=20 dB HL; recommended prior experience with fitted hearing aids<=45 dB HL (BC); <=20 dB HL (AC) for SSD
From FDA labeling and ECRI assessment
Osia / Osia 2 (Cochlear): Osia and Osia 2 indications: PTA BC <=55 dB HL (0.5,1,2,3 kHz); patients 12+; bilateral fit for symmetric losses (<10 dB average or <15 dB at individual frequencies); SSD: profound SNHL in one ear with normal hearing in opposite ear (AC PTA <=20 dB HL); prior experience with fitted hearing aids recommended<=55 dB HL (BC); <=20 dB HL (AC) for SSD
From FDA labeling
ADHEAR System: intended for all ages with unilateral or bilateral conductive hearing loss or SSD; PTA BC <=25 dB HL (0.5,1,2,3 kHz); retained with elastic headband or adhesive adapter behind auricle<=25 dB HL (BC)
From FDA labeling
Earlens (light-driven): Earlens Contact Hearing Aid: adults 18+ with mild to severe sensorineural hearing impairment; provides amplification 125 Hz to 10,000 Hz
From FDA labeling
SoundBite (intraoral): SoundBite intraoral bone conduction system: FDA cleared 2011; manufacturing ceased 2015 (informational)
From FDA clearance information