Clinical trial: Esteem New Subject Enrollment Post Approval Study (NCT02689349)

Eligibility criteria:
Inclusion Criteria:

          1. Subject is ≥ 18 years old

          2. Subject understands the nature of the procedure and has signed the Subject Informed
             Consent Form prior to the procedure

          3. Subject is willing and able to comply with specified follow-up evaluations and
             understands the audiological test procedures and use of the Esteem® System.

          4. Subject has moderate to severe sensorineural hearing loss in the ear to be implanted
             defined by pure tone average air-conduction threshold level.

          5. Subject has an unaided maximum word recognition score of greater than or equal to 40%
             with recorded delivery using a phonetically balanced word list at SRT + 40 decibels
             (dB) or at maximum tolerable presentation level.

          6. Subject is a current user of a properly functioning and appropriately fit hearing aid
             for at least one (1) month in the ear to be implanted.

          7. Subject has normally functioning eustachian tube

          8. Subject has normal tympanic membrane

          9. Subject has a normal middle ear anatomy

         10. Subject has adequate space for Esteem® System implant determined via fine cut temporal
             bone CT scan

         11. Subject is a native speaker of the English language.

        Exclusion Criteria:

          1. Subject has a history of post-adolescent chronic middle ear infections, inner ear
             disorders or recurring vertigo requiring treatment, disorders such as mastoiditis,
             Hydrops or Meniere's syndrome or disease

          2. Subject has a history of otitis externa or eczema for the outer ear canal and the
             investigator believes this will affect the Esteem® System implantation

          3. Subject has cholesteatoma or destructive middle ear disease

          4. Subject has life expectancy of < two (2) years due to other medical conditions

          5. Subject has retrocochlear or central auditory disorders

          6. Subject is known to be suffering from any psychological, developmental, physical, or
             emotional disorder that the investigator feels would interfere with the surgery or
             follow-up testing

          7. Subject has a known history of fluctuating air conduction and/or bone conduction
             hearing loss over a one-year period of 15 dB in either direction at 2 or more
             frequencies (from 500 - 4000 Hz)

          8. Subject has sudden hearing loss due to unknown cause

          9. Subject has a history of disabling tinnitus, defined as tinnitus which required
             treatment.

         10. Subject is unable to adequately perform audiological testing

         11. Subject has a medical condition or undergoing a treatment that may affect healing and
             the investigator does not believe the subject is a good candidate for the trial.

         12. Subject has diabetes that is not well controlled with medication or diet and the
             investigator does not believe in his best medical judgment that the subject would be a
             good candidate for the trial

         13. Subject is pregnant at the time of device implant

         14. Subject has a history of keloid formation

         15. Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel,
             titanium and/or gold
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