SPI-1005 to help preserve hearing during cochlear implant surgery

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant

This trial will test whether taking SPI-1005 (ebselen) around the time of surgery is safe and helps preserve hearing and reduce tinnitus or vertigo in adults receiving a MED‑EL long‑array cochlear implant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sound Pharmaceuticals, Incorporated (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Charleston, South Carolina)
• Trial ID: NCT06340633 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with post‑lingual, bilateral severe‑to‑profound sensorineural hearing loss who are scheduled to receive a MED‑EL FLEX26 or longer cochlear implant and meet the specified baseline low‑frequency hearing thresholds.

Not a fit: Patients with negligible residual low‑frequency hearing, recent exposure to IV ototoxic drugs, or those receiving non‑MED‑EL devices are less likely to benefit from the treatment tested in this protocol.

Why it matters

Potential benefit: If successful, SPI‑1005 could help preserve residual low‑frequency hearing after cochlear implantation and reduce tinnitus or vestibular symptoms, improving post‑implant speech recognition and quality of life.

How similar studies have performed: Preclinical and early‑phase human studies of ebselen have shown protective effects against oxidative inner‑ear damage, but clinical evidence specifically supporting cochlear‑implant hearing preservation is limited.

Eligibility criteria

Inclusion Criteria:

* Adults who are ≥18 years of age at time of consent.
* Post-lingual, bilateral, severe 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:

  * ≥40 and ≤70 dB HL at 125, 250, and 500 Hz; AND
  * ≥80 dB HL at 2000 through 8000 Hz.
* 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 enrollment, 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 enrollment.
* Female patients who are pregnant or breastfeeding.
* Air conduction thresholds at baseline in the ear scheduled to receive the cochlear implant with any No Response at 125 through 8000 Hz.

Where this trial is running

Charleston, South Carolina

• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Study coordinator: Jonathan Kil, MD

Conditions Hearing Loss; Cochlear Trauma; Hearing Preservation; Cochlear Implant; SPI-1005; Ebselen