SPI-1005 for Hearing Loss in Adults Getting a Cochlear Implant
Tests SPI-1005 against placebo in adults receiving a cochlear implant.
Key facts
- Who runs it
- Sound Pharmaceuticals, Incorporated
- Where
- Charleston, Columbus, Dallas, Iowa City, Milwaukee, and Philadelphia, United StatesSee the 6 sites
- Trial code
- Registry title
- SPI-1005 in Adults Receiving Cochlear Implant
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 40 people, planned
- Starts
- Dec 2026
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Ebselen
- Placebo
- Record updated
- 26 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with hearing loss in both ears who are scheduled to get a MED-EL cochlear implant (long electrode array, FLEX26 or greater) in one ear.
- Age
- 18 years and older.
- Sex
- All sexes can join.
- Disease stage
- Moderate to profound sensorineural (inner ear) hearing loss in both ears, which started after learning to speak. In the ear to be implanted, hearing levels must be ≤70 dB HL at 125, 250 and 500 Hz, and ≥70 dB HL at 2000, 4000 and 8000 Hz. The middle ear test (tympanogram) must be Type A (including As and Ad).
- Earlier treatment
- No IV drugs that can harm hearing now or within 60 days before consent. Examples are cisplatin, carboplatin, oxaliplatin, gentamicin, amikacin, tobramycin, kanamycin, streptomycin or furosemide.
Main reasons for not taking part
- Taking part in another study of an experimental drug or device within 90 days before consent.
- Women who are pregnant or breastfeeding.
- Moderate or severe liver problems (Child-Pugh Score >6 points).
- No measurable hearing response at three or more frequencies in a row in the ear to be implanted.
- Middle ear that does not move (Type B tympanogram) or abnormal middle ear pressure (outside -150 to +50).
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Moderate or severe hepatic impairment using Child-Pugh Score (>6 points)
- Female patients who are pregnant or breastfeeding
- No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range)
Where in United States
- Medical University of South CarolinaCharleston, United StatesContact: Research DirectorTaking people
- Ohio State UniversityColumbus, United StatesContact: Beth Miles-MarkleyTaking people
- University of Texas, SouthwesternDallas, United StatesContact: Paula Arellano-CruzTaking people
- University of IowaIowa City, United StatesContact: Lead Clinical Research CoordinatorTaking people
- Medical College of WisconsinMilwaukee, United StatesContact: Clinical Research CoordinatorNot yet recruiting
- Thomas Jefferson UniversityPhiladelphia, United StatesContact: Morgan KyserTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- SPI-1005 400 mg twice daily (BID)Treatment being tested
Oral administration of ebselen (SPI-1005) 400 mg BID for 180 days
Treatment: Ebselen
- PlaceboPlacebo, for comparison
Oral administration of matching placebo BID for 180 days
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant
- Plain-language title
- SPI-1005 for Hearing Loss in Adults Getting a Cochlear ImplantGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 26 June 2026