Clinical Trials

Inclusion Criteria:

Subjects must meet ALL of the following criteria:

• Signed and dated informed consent form.
• At least 18 years of age at time of implant.
• Good health and absence of significant morbidity.
• Ability to read, write, comprehend, and speak fluently in English.
• Post-lingually deafened.
• Pure-tone thresholds indicate at least a bilateral moderate-to-severe sensorineural hearing loss:
  • Low frequency pure-tone average greater than or equal to 40 dB HL at 250, 500, 750, and 1,000 Hz; and
  • Severe or profound hearing loss greater than or equal to 70 dB HL at 2 KHz and above.
• Limited benefit from amplification, defined by aided CNC word recognition ≤ 40% in the ear to be implanted and ≤ 60% in the best aided condition.
• Normal middle ear function based on otoscopy and tympanometry (Type A, AS, or AD).
• An accessible cochlear lumen and intact cochlear nerve, and no known lesions on the auditory nerve or acoustic areas of the central nervous system.
• Ability to undergo surgery and post-implant rehabilitation.

Exclusion Criteria:

Subjects will be excluded if any of the following are present:

• More than ten years of documented severe-to-profound hearing loss.
• Air-bone gap greater than 10 dB at two of the four following frequencies: 500, 1000, 2000, and 4000 Hz.
• Prior surgery in the middle ear, inner ear, neck, or infraclavicular region that is anticipated to prevent proper placement or function of the Acclaim CI.
• Ossification, malformation, or any other cochlear anomaly that might prevent complete insertion of the electrode array.
• Hearing impairment due to retrocochlear pathology.
• Diagnosed auditory neuropathy.
• Unwillingness or inability of the candidate to comply with all required investigational testing and follow-up visits, in the opinion of the Investigator.
• Known hypersensitivity or contraindication to procedural or post-procedural medications that cannot be adequately managed medically.
• Known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium, or platinum.
• Currently using other active implants that are expected to interfere with the Acclaim CI positioning or function.
• Participation or planned participation in an investigational drug or another device study within the three months prior to screening. Participation in clinical trials or registries where only measurements and/or samples are taken (e.g., no test device or test drug) is allowed.
• Pregnancy at the time of implant or plans to become pregnant within two (2) years of enrollment.

Eligibility last updated 11/16/21. Questions regarding updates should be directed to the study team contact.