Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Advanced Bionics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
General Requirements:
Ability to provide Informed Consent
18 years of age or older
English language proficiency
Willingness to participate in all scheduled procedures outlined in the study investigational plan
Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study
Ear to be Implanted:
Severe-to-profound sensorineural hearing loss (\> 70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
CNC word recognition score ≤30% (tested in subject's everyday listening condition for that ear)
Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) \>3 months and ≤10 years in the ear to be implanted only
Contralateral (non-implanted) ear:
Up to a moderate sensorineural hearing loss (\<70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
CNC word recognition score \>30% (tested in subject's everyday listening condition for that ear)
You may not be if
Previous experience with a cochlear implant
Cochlear malformation or obstruction (i.e. ossification) that would preclude full insertion of electrode array in the ear to be implanted
Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator
Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear
Active middle-ear disease/infection in the ear to be implanted
Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator
Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator
Clareo Health | Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
