Clinical trial: Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness (NCT01670006)

Eligibility criteria:
Inclusion Criteria:

          1. Ability to provide informed consent.

          2. Eighteen years-of-age or older at the time of implantation.

          3. Presence of single-sided deafness as follows:

               1. Poorer ear (ear to be implanted):

                    -  severe to profound sensorineural hearing loss, defined as pure-tone
                       thresholds 80 dB HL or greater for the frequencies 500, 1000, 2000, 3000,
                       and 4000 Hz.

                    -  Monosyllabic word understanding, as measured using the CNC Word Test at 60
                       dBA under earphones, less than or equal to 10%.

               2. Better ear (contralateral ear):

                    -  Normal or near-normal hearing, defined as pure-tone thresholds no poorer
                       than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB
                       HL at 4000 Hz.

                    -  Monosyllabic word understanding, as measured using the CNC Word Test at 60
                       dBA under earphones, of greater than or equal to 90%.

          4. Duration of severe to profound sensorineural hearing loss of at least 6 months (to
             ensure stability of hearing loss) but no greater than 10 years.

          5. English spoken as a primary language.

        Exclusion Criteria:

          1. Alleviation of tinnitus as the stated primary or sole motivation for seeking
             implantation by the subject and/or investigator.

          2. Actively using an implantable device in the poorer ear.

          3. Onset of severe to profound hearing loss < 6 years-of-age.

          4. Evidence of active middle-ear pathology based on otologic examination and/or
             immittance testing.

          5. Medical or psychological conditions that contraindicate undergoing surgery.

          6. Ossification or any other cochlear anomaly at the implant ear that might prevent
             complete insertion of the electrode array.

          7. Hearing loss of neural or central origin, including auditory neuropathy.

          8. Unrealistic expectations on the part of the subject regarding the possible benefits,
             risks, and limitations inherent to the surgical procedure and prosthetic device.

          9. Unwillingness and/or inability of the candidate to comply with all investigational
             requirements including, but not limited to, study protocol and surgical procedure, 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