Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing

Ki vehet részt

• 18 years-of-age or older at the time of surgery
• Low-frequency threshold at 500 Hz ≤ 50 dB HL and high-frequency pure-tone average (PTA), 2000-8000 Hz ≥ 65 dB HL in the ear to be implanted
• Pure-tone average (PTA) (0.5k, 1k, 2k Hz) > 30 dB HL in the contralateral ear
• CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear
• English spoken as a primary language
• Willing and able to provide written informed consent

Ki nem vehet részt

• Individuals greater than or equal to 70 years at the time of surgery
• Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age
• Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device
• Active middle-ear infection
• Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
• Duration of severe to profound sensorineural hearing loss > 20 years per self-report
• Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
• Conductive overlay of 15 dB or greater at two or more frequencies, in the range of 250 through 1000 Hz in the ear to be implanted
• Hearing loss of neural or central origin
• Diagnosis of Auditory Neuropathy
• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the device and/or procedure, as determined by the Investigator
• Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator
• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
• Investigator site personnel directly affiliated with this study and/or their immediate family (spouse, parent, child, or sibling)
• Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation