SPI-1005 to help preserve hearing during cochlear implant surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial enrolls adults receiving a long electrode array (FLEX26 or greater) from MED‑EL into one ear and compares oral SPI‑1005 (ebselen) to a matching placebo. Participants begin study drug two days before implantation and continue treatment for six months, with five required in‑clinic visits for testing. The study measures safety and tolerability and tracks hearing thresholds, word recognition, speech discrimination, tinnitus, and vertigo outcomes after implantation. Results will inform whether SPI‑1005 can prevent or reduce hearing loss and other cochlear‑implant–related side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• University of Iowa
  Iowa City, Iowa, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting
• Thomas Jefferson University
  Philadelphia, Pennsylvania, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• University of Texas Southwestern
  Dallas, Texas, United States Recruiting
• Medical College of Wisconsin
  Milwaukee, Wisconsin, United States Not yet recruiting

Study contacts

• Study coordinator: Jonathan Kil, MD
• Email: info@soundpharma.com
• Phone: 2066342559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.