Clinical trial: Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode (NCT01959152)

Eligibility criteria:
Inclusion Criteria:

          -  No previous cochlear implant experience

          -  18 years of age or older

          -  Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone
             average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound
             sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for
             2,000, 4,000, and 8,000 Hz) in the ear to be implanted

          -  Aided monosyllabic word score of 10-50% in the ear to be implanted

          -  Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone
             average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound
             sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for
             2,000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear

          -  English language proficiency

          -  Willingness to participate in all scheduled procedures outlined in the protocol

        Exclusion Criteria:

          -  Previous inner ear surgery

          -  Cochlear malformation or obstruction that would preclude full insertion of electrode
             array

          -  Presence of additional disabilities that would prevent or interfere with participation
             in the required study procedures

          -  Medical or psychological conditions that contraindicate surgery or impact the ability
             to manage an implanted device or the study-related procedures

          -  Evidence of central auditory lesion or compromised auditory nerve
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 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? 0