Device-specific labeled indications and audiometric thresholds per professional/FDA labeling:
Vibrant Soundbridge selection criteria: Adults aged 18 years or older; audiological results consistent with moderate to severe sensorineural hearing loss; pure-tone air conduction threshold levels within specified frequency ranges; Word Recognition Score of 50% or better; normal middle-ear anatomy; psychologically and motivationally suitable.500 Hz: 30-65 dB; 1,000 Hz: 40-75 dB; 1,500 Hz: 45-80 dB; 2,000 Hz: 45-80 dB; 3,000 Hz: 50-85 dB; 4,000 Hz: 50-85 dB
Per FDA professional labeling for Vibrant Soundbridge (PMA).
MAXUM Hearing Implant selection criteria: Adults aged 18 years or older; audiological results consistent with moderate to severe sensorineural hearing loss; desire for an alternative to an acoustic hearing device; experience with appropriately fit hearing aids.
Per FDA labeling for MAXUM (Soundtec/Maxum).
BAHA System (general) indications: Adults with malformations of the external ear or chronically draining ear; pure-tone threshold hearing loss of ≥ 45 dB; inability or unwillingness to use an air conduction hearing aid.
Initial BAHA clearances and pediatric extension to age 5+.
BAHA bilateral implantation (2001): Moderate to severe, bilateral, symmetrical conductive or mixed hearing loss; average bone conduction thresholds better than 45 dB HL; symmetry defined as <10 dB average or <15 dB at individual frequencies (500,1,2,4 kHz).
FDA 2001 bilateral indication.
BAHA for SSD (2002): Unilateral sensorineural deafness with normal hearing in the other ear; normal hearing defined as PTA air conduction ≤ 20 dB (0.5,1,2,3 kHz).
FDA 2002 SSD indication.
Sophono (Otomag Alpha 1) indications: Patients with conductive or mixed hearing loss benefiting from amplification; PTA bone conduction threshold better than 45 dB HL (0.5,1,2,3 kHz); bilateral fitting for symmetric loss with interaural diff <10 dB avg or <15 dB at individual frequencies; SSD criteria where hearing ear PTA air conduction ≤ 20 dB HL.
Per Otomag/Sophono FDA clearance (May 2011).
Cochlear Baha Attract indications (2013): Patients aged 5 years or older; conductive or mixed hearing loss with PTA bone conduction <=45 dB HL for BP100 processor and <=55 dB HL for BP1100 processor (0.5,1,2,3 kHz); bilateral fitting for symmetric losses; SSD: unilateral SN deafness with other ear PTA air conduction ≤20 dB HL.BP100 <=45 dB HL; BP1100 <=55 dB HL
Per Cochlear Baha Attract FDA clearance (2013).
BONEBRIDGE indications (2018/2019): Patients 12 years or older; conductive or mixed hearing loss with PTA bone conduction ≤45 dB HL (0.5,1,2,3 kHz); bilateral fitting for symmetrical loss (interaural diff <10 dB avg or <15 dB at individual frequencies); SSD criteria with hearing ear PTA air conduction ≤20 dB HL; recommended prior experience with appropriately fit air or bone conduction hearing aids.<=45 dB HL
Per BONEBRIDGE de novo/510(k) clearances.
Osia System / Osia 2 indications (2019): Patients 12 years or older; conductive or mixed hearing loss with PTA bone conduction ≤55 dB HL (0.5,1,2,3 kHz); bilateral fitting for symmetric loss; SSD criteria with hearing ear PTA air conduction ≤20 dB HL; recommended prior experience with appropriately fitted air or bone conduction hearing aids.<=55 dB HL
Per Osia FDA 510(k) approvals.
Baha nonimplantable/headband/softband indications: Any age may use SoundBand, Softband, or SoundArc; implants for age 5 and older; conductive or mixed hearing loss with PTA bone conduction thresholds per processor-specific limits (examples: <=45 dB HL for BP100/Baha 4/5; <=55 dB HL for BP110 Power/Baha 5 Power; <=65 dB HL for Cordelle II/Baha 5 SuperPower); bilateral fitting for symmetric losses; SSD criteria with hearing ear PTA air conduction ≤20 dB HL.<=45/55/65 dB HL depending on processor
Per Cochlear Baha FDA clearances and SoundArc/BP100/BP110 indications.
Cochlear Baha 7 Sound Processor (2025): Any age may use SoundBand/Softband/SoundArc; age 5+ for implant; conductive or mixed hearing loss with PTA bone-conduction ≤55 dB HL (0.5,1,2,3 kHz); bilateral fitting for symmetric moderate to severe loss; SSD criteria with hearing ear PTA air conduction ≤20 dB HL.<=55 dB HL
Per 2025 FDA clearance for Baha 7.