Clinical Trials

Inclusion Criteria:

• Provision of signed and dated informed consent form.
• Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
• Minimum of 30 days experience with appropriately fit binaural amplification (standardized NAL fitting method) verified with real ear measurements within 5 dB SPL of targets.
• Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
  • The ear to implanted: CNC words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct);
  • Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct);
  • Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted;
  • Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted;
  • Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear.
• Proficient in English.
• Undergoing implantation with a current generation cochlear implant device from either Cochlear Limited or Advanced Bionics AG.
• Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624.
• Advanced Bionics AG devices include:  HiFocus SlimJ, Mid-Scala.
• Stated willingness and ability to complete testing and all associated study visits.

Exclusion Criteria:

• An individual who meets any of the following criteria will be excluded from participation in this study:
  • Previous cochlear implantation;
  • Prelingual onset of hearing loss;
  • Abnormal inner ear anatomy on CT imaging;
  • Auditory neuropathy spectrum disorder;
  • Retrocochlear pathology such as a vestibular schwannoma or stroke.
• Unwillingness or inability to comply with all investigational requirements including the randomization process.
• Additional medical, or social barriers that would prevent completion of all study requirements.
• Medical condition contraindicated for surgery.
• Device selection of Med El cochlear implant (per the patient’s selection).