Clinical trial: Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss (NCT02811549)

Eligibility criteria:
Inclusion Criteria:

        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)

        Exclusion Criteria:

          -  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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? Entailment