Charleston, SCNCT06340633Now EnrollingIRB Ready

Hearing Loss Clinical Trial in Charleston, SC

Access cutting-edge hearing loss treatment through this clinical trial at a research site in Charleston. Study-provided care at no cost to qualified participants.

Sponsored by Sound Pharmaceuticals, Incorporated

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Expert Care in Charleston

Access hearing loss specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hearing loss treatment provided free

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Check if you qualify for this hearing loss clinical trial in Charleston, SC

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Why Participate?

  • No-Cost Study Care

  • Local to Charleston

    Convenient for SC residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Charleston site if eligible
  4. 4Begin participation

About This Hearing Loss Study in Charleston

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.

Sponsor: Sound Pharmaceuticals, Incorporated

Who Can Participate

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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Charleston?

Yes, this clinical trial (NCT06340633) has an active research site in Charleston, SC that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hearing Loss Treatment Options in Charleston, SC

If you're searching for hearing loss treatment options in Charleston, SC, this clinical trial (NCT06340633) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Charleston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hearing loss specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

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Secure · Expert Care · Charleston, SC