Clinical trial: Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants (NCT03929809)

Eligibility criteria:
Inclusion Criteria:

          1. Participants will be adults who utilize English as their primary language.

          2. Unilateral severe to profound sensorineural hearing loss for a duration of at least 6
             months (to ensure stability of hearing loss), but no greater than 10 years.

          3. Contralateral ear with normal, or near-normal, hearing.

          4. Poorer ear (ear to be implanted): severe to profound sensorineural hearing loss,
             defined as pure-tone thresholds 70 dB HL or greater for the frequencies 500, 1000,
             2000, 3000, and 4000 Hz with monosyllabic word understanding, as measured using the
             CNC Word Test at 60 dBA under earphones, less than or equal to 20%

          5. 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 with monosyllabic word understanding, as measured using the
             CNC Word Test at 60 dBA under earphones, of greater than or equal to 85%.

          6. Willingness to comply with all study requirements.

          7. Patent cochlea and normal cochlear anatomy.

        Exclusion Criteria:

          1. Medical or psychological conditions that contraindicate undergoing surgery.

          2. Ossification or any other cochlear anomaly that might prevent complete insertion of
             the electrode array.

          3. Unrealistic expectations on the part of the candidate and/or candidate's family,
             regarding the possible benefits, risks, and limitations that are inherent to the
             surgical procedure(s) and prosthetic devices.

          4. Unwillingness or inability of the candidate to comply with all investigational
             requirements.

          5. Active middle ear infection.

          6. Tinnitus primary motivation for implantation.
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