SPI-1005 in Adults Receiving Cochlear Implant

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Hearing Loss, Cochlear Trauma

In brief

The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear. The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005? The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant. Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests. The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.

Key facts

Study ID: NCT06340633
Run by: Sound Pharmaceuticals, Incorporated
People needed: 40
Starts: 2026-12-01
Expected to finish: 2026-12-01
Last updated by the study team: 2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 qualify 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).

Where it is running

University of Iowa — Iowa City, Iowa, United States (enrolling)
Ohio State University — Columbus, Ohio, United States (enrolling)
Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
University of Texas Southwestern — Dallas, Texas, United States (enrolling)
Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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