Adults who are ≥18 years of age at time of consent.
Post-lingual, bilateral, moderate to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:
* ≤70 dB HL at 125, 250, and 500 Hz; AND
* ≥70 dB HL at 2000, 4000, and 8000 Hz.
Type A (including As and Ad) tympanogram at baseline in the ear scheduled to receive the cochlear implant.
Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.
You may not be if
Current, or within 60 days prior to study consent, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
Participation in another investigational drug or device study within 90 days prior to study consent.
Female patients who are pregnant or breastfeeding.
Moderate or severe hepatic impairment using Child-Pugh Score (\>6 points).
No measurable air conduction response at three or more consecutive test frequencies (e.g., 2000, 4000 and 8000 Hz) at baseline in the ear scheduled to receive the cochlear implant.
No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range).
Clareo Health | SPI-1005 in Adults Receiving Cochlear Implant
