Clinical trial: Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness (NCT02189798)

Eligibility criteria:
Inclusion criteria: Newly Implanted Group:

          -  Ability to provide informed consent

          -  No previous cochlear implant experience in either ear

          -  18 years of age or older

          -  Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone
             average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural
             hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000,
             4,000, and 8,000 Hz) in the ear to be implanted

          -  Aided CNC word recognition score up to 50% in ear to be implanted

          -  Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone
             average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural
             hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000,
             4,000, and 8,000 Hz) in the contralateral (non-implanted) ear

          -  Aided CNC word recognition score up to 80% in the contralateral ear

          -  English language proficiency

          -  Willingness to use an ear-level sound processor postoperatively for the duration of
             the study trial

          -  Willingness to participate in all scheduled procedures outlined in the protocol

        Exclusion Criteria: Newly Implanted Group:

          -  Preoperative audiometric conductive overlay of 15 dB or greater at two frequencies or
             more in range of 500-1000 Hz in the ear to be implanted

          -  Congenital hearing loss (for purpose of this study, onset prior to age 2 years*).
             *Based on critical period for speech and language development

          -  Duration greater than 30 years of severe-to-profound high-frequency hearing loss

          -  Cochlear malformation or obstruction 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

          -  Deafness due to central auditory lesion or cochlear nerve deficiency, 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

        EAS Fitting Inclusion Criteria: Newly Implanted and Existing Implanted Groups

          -  Ability to provide informed consent

          -  18 years of age or older, unilaterally implanted with HiRes90K™ Advantage cochlear
             implant with HiFocus™ Mid-Scala electrode and fit with an ear-level sound processor
             (i.e. Naída family device)

          -  Postoperative unaided low frequency audiometric hearing thresholds in the treated ear
             up to 80 dB HL for at least one frequency from 125 - 1000 Hz

          -  English Language Proficiency

          -  Willingness to participate in all scheduled procedures outlined in the study protocol

        EAS Fitting Exclusion Criteria: Newly Implanted and Existing Implanted Groups

          -  Unilaterally implanted with HiRes 90K™ Advantage cochlear implant with HiFocus™ Helix®
             and HiFocus™ 1j electrode

          -  Exclusive use of a body worn external sound processor

          -  Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of
             auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear

          -  Postoperative unaided low frequency audiometric hearing thresholds in the treated ear
             exceeding 80 dB HL at each frequency from 125 - 1000 Hz 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? 1