Clinical trial: Single-Sided Deafness and Asymmetric Hearing Loss (NCT04506853)

Eligibility criteria:
Inclusion Criteria:

          -  Five years of age or older at the time of implantation

          -  Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000,
             and 4000 Hz) of 90 dB or greater in the ear to be implanted

          -  Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap
             less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and
             4000 Hz and a diagnosed pathology of the outer or middle ear

          -  Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined
             by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less

          -  Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet

          -  Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS)
             hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction,
             or traditional hearing aid, as deemed appropriate by investigator

          -  Fluent in English

        Exclusion Criteria:

          -  Duration of profound hearing loss of 10 years or more

          -  Absence of cochlear development or non-functionality of cochlear nerve

          -  Other retrocochlear hearing loss

          -  Evidence of severe cochlear malformation (i.e., common cavity or ossification)

          -  External or middle ear infection

          -  Suspected developmental or cognitive concern

          -  Other medical contraindication for surgery or anesthesia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 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