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Tests treatment safety and results for Hearing Loss, Bilateral Sensorineural
Official title A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
ClinicalTrials.gov ID: NCT07287124
What this study is testing
- What it's testing
- This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system. The system includes a microphone placed under the skin to detect speech and sound from the environment, providing the option to hear without any visible external parts.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individuals aged 18 years and older at time of consent.
- Clinically established sensorineural hearing loss (SNHL) defined by a four frequency (500, 1000, 2000, 4000 Hz) pure-tone average unaided threshold...
- Compromised functional hearing in the aided condition defined as ≤40% correct on a word recognition test in the ear to be implanted.
- Clinically established SNHL defined by a four-frequency (500, 1000, 2000 \& 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥30 dB HL in the...
- Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator.
You likely can't join if
- Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to...
- Candidates with single-sided deafness as determined by the investigator.
- Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
- Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted...
- Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.
- Previously reported diagnosis of auditory neuropathy, in the ear to be implanted.
See the full eligibility criteria
- Individuals aged 18 years and older at time of consent.
- Clinically established sensorineural hearing loss (SNHL) defined by a four frequency (500, 1000, 2000, 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥70 dB HL in the ear to be implanted.
- Compromised functional hearing in the aided condition defined as ≤40% correct on a word recognition test in the ear to be implanted.
- Clinically established SNHL defined by a four-frequency (500, 1000, 2000 \& 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥30 dB HL in the contralateral ear.
- Candidate is a fluent speaker in the language used to assess speech perception performance as determined by the investigator.
- Direct access to a compatible Smart Phone.
- Willing and able to provide written informed consent.
- Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
- Candidates with single-sided deafness as determined by the investigator.
- Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
- Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment.
- Presence of a tympanic membrane perforation or a history of otologic surgery within 3 months prior to enrolment, in the ear to be implanted.
- Previously reported diagnosis of auditory neuropathy, in the ear to be implanted.
- Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, in the ear to be implanted.
- Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, skull fracture or CSF leaks.
- Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the participant.
- Severe, or poorer, sensorineural hearing loss for more than 20 years, as reported by the participant, in the ear to be implanted.
- Medical or psychological conditions that contraindicate general anaesthesia, surgery, or participation in the clinical investigation as determined by the investigator.
- Pre-existing skin condition that could jeopardize wound healing as judged by the investigator e.g., psoriasis, dermatitis, use of corticosteroids, uncontrolled diabetes.
- Unrealistic expectations on the part of the participant, regarding the possible benefits, risks, and limitations inherent to the surgical procedure(s) and prosthetic devices, as determined by the Investigator.
- Additional disabilities that may affect the participant's participation or safety during the clinical investigation.
- Unable or unwilling to comply with all requirements of the clinical investigation, as determined by the investigator.
- Pregnant or breastfeeding women.
- Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as spouse, parent, child or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of the investigation.
- Current participation, or participation in another treatment clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to...
The study team makes the final eligibility decision.
Where it's taking place
- Englewood, Colorado, United States
- Miami, Florida, United States
- Iowa City, Iowa, United States
- Novi, Michigan, United States
- Rochester, Minnesota, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Beachwood, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Englewood, Colorado, United States; Miami, Florida, United States; Iowa City, Iowa, United States; Novi, Michigan, United States; Rochester, Minnesota, United States; Kansas City, Missouri, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.