Clinical trial: Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy (NCT01337076)

Eligibility criteria:
Inclusion Criteria:

          -  Eighteen years of age or older at the time of the study.

          -  Preoperative aided CNC word score in quiet of greater than or equal to 10% and less
             than or equal to ¬¬40% in the ear to be implanted; equal to but no better than 50% in
             the contralateral ear

          -  Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and
             profound sensorineural hearing loss in the high speech frequencies (3000 Hz and above)

          -  Willingness to use bimodal stimulation (i.e. a cochlear implant on one ear and a
             hearing aid on the contralateral ear) through at least 6-months postactivation.

          -  English spoken as the primary language.

        Exclusion Criteria:

          -  Congenital hearing loss (for the purpose of this study, onset prior to 2
             years-of-age).

          -  Preoperative aided HINT sentence score less than or equal to 50% in the ear to be
             implanted

          -  Ossification, absence of cochlear development or any other cochlear anomaly that might
             prevent complete insertion of the electrode array.

          -  Hearing loss of neural or central origin (e.g., deafness due to lesions on the
             acoustic nerve or central auditory pathway).

          -  Active middle-ear infection.

          -  Unwillingness and/or inability of the candidate to comply with all investigational
             requirements including, but not limited to, study protocol and surgical procedure.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
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