Clinical trial: Osia CPT Code Study (NCT04320407)

Eligibility criteria:
Inclusion Criteria:

          -  Cohort 1 Osia:

               -  Willing and able to provide written informed consent.

               -  Proficient in English.

               -  Hearing loss etiology of Conductive or Mixed Conductive loss.

               -  Bone conduction PTA (.5, 1, 2, and 3 kHz) better than or equal to 55 dB HL in the
                  treatment ear.

               -  Aged 18 years and older.

        Exclusion Criteria:

          -  Cohort 1 Osia:

               -  Unwilling to wear the treatment device or comply with the surgical and
                  rehabilitation requirements of the study.

               -  Unable or unwilling to comply with the requirements of the clinical investigation
                  as determined by the Investigator.

               -  Medical, audiological or psychological conditions, as judged by the investigator
                  that might contraindicate participation in the clinical investigation.

               -  Investigator site personnel directly affiliated with this study and/or their
                  immediate families; immediate family is defined as a spouse, parent, child, or
                  sibling.

               -  Cochlear employees or contractors engaged by Cochlear for the purposes of this
                  investigation.

               -  Currently participating, or participated within the last 30 days, in another
                  interventional clinical investigation/trial involving an investigational drug or
                  device.

               -  Prior experience with a surgical bone conduction treatment option

               -  Insufficient bone quality to support the BI300 implant as determined by the
                  surgeon
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? Entailment