Clinical trial: Safety and Efficacy of the Vibrant Soundbridge (VSB) for Mixed and Conductive Hearing Losses (NCT00748540)

Eligibility criteria:
Inclusion Criteria:

          -  Adults, 18 years of age or older at time of implantation

          -  English as the primary language

          -  Appropriate motivation and expectation levels

          -  Geographically and physically able to return to the investigational center for
             scheduled evaluations and follow-up appointments.

          -  At least a 28-day unsuccessful hearing aid trial (within the past 24 months prior to
             enrolment).

          -  Persons who after being informed that a different hearing aid than the one they
             currently have may provide improved hearing, still request an implant.

          -  Ability to undergo general anesthesia

          -  Audiological tests suggest either a conductive or mixed hearing loss. The
             non-implanted ear may fall outside these criteria; however, threshold levels may not
             be worse than severe sloping to profound.

          -  Conductive Hearing Loss

          -  Pure-tone bone-conduction threshold levels in the ear to be implanted shall fall at or
             within the levels stated below. There should be an air-bone gap of 15 dB HL or more at
             three or more of the frequencies 500, 1000, 1500, 2000, 3000, and 4000 Hz. Pure-tone
             air-conduction levels should indicate the presence of at least a moderate hearing loss
             of at least 41 dB HL. Air conduction levels are not limited on the upper end.

          -  Upper Limits of Bone Conduction Thresholds for Conductive Hearing Loss Frequency (kHz)
             0.5 1.0 1.5 2.0 3.0 4.0 Bone Conduction upper limit (dBHL) <25 <25 <25 <25 <25 <25

          -  Mixed Hearing Loss

          -  Pure-tone bone conduction threshold levels in the ear to be implanted shall fall at or
             within the levels stated below. There should be an air-bone gap of 15 dB HL or more at
             three or more of the frequencies 500, 1000, 1500, 2000, 3000, and 4000 Hz. Bone
             conduction thresholds at least three of the frequencies should be 26 dB or greater.
             Pure-tone air-conduction thresholds should be, on average, at least moderately
             impaired of 41 dB or greater. Air-conduction levels are not limited on the upper end.

          -  Lower and Upper Limits of Bone Conduction Thresholds for Mixed Hearing Loss Frequency
             (kHz) 0.5 1.0 1.5 2.0 3.0 4.0 Bone Conduction lower limit (dBHL) 0 0 0 0 0 0 Bone
             Conduction upper limit (dBHL) 45 50 55 65 65 65

          -  Good potential for aided speech recognition as indicated by a pre-operative
             monosyllabic word score of > 30% in the ear to be implanted as measured under
             headphones at 40 dB SL or at MCL

          -  Hearing aid trial with appropriately fitted hearing aids of at least 28 days duration
             within the past 24 months, unless the subject is unable to wear hearing aids for
             medical reasons

          -  Most recent audiometric data, if available, judged to be of good test-retest
             reliability.

        Exclusion Criteria:

          -  Hearing loss of purely sensorineural origin

          -  Retrocochlear or central auditory disorders

          -  Active middle ear infection

          -  Tympanic membrane perforation, ears with previously reconstructed tympanic membranes
             may be included

          -  Bone-conduction thresholds in the ear to be implanted that have demonstrated a recent
             fluctuation at two or more frequencies of 15 dB in either direction in the last 6
             months, as demonstrated by serial audiograms.

          -  History of post-adolescent, inner-ear disorders, such as vertigo or labyrinthitis

          -  Chronic or non-revisable vestibular or balance disorders

          -  Middle ear infections not responsive to medical treatment

          -  Skin or scalp conditions that may preclude attachment of the Audio Processor or that
             may interfere with the use of the Audio Processor

          -  Chronic pain in or around the head

          -  Current or previous use of an active hearing implant in either ear.

          -  Any known physical, psychological, or emotional disorder that may interfere with the
             completion of scheduled follow-up evaluations

          -  Developmental delays or organic brain dysfunction
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