Clinical trial: Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System (NCT04041700)

Eligibility criteria:
Inclusion Criteria:

          -  Subject with conductive hearing loss or mixed hearing loss in the ear to be implanted.
             Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 4 kHz)
             of ≤ 55 dB sensorineural hearing loss.

        OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery.
        Air conduction thresholds with a pure tone average PTA4 (mean of 0.5, 1, 2 and 3 kHz) of ≤
        20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air
        Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not
        use an AC CROS.

          -  Adult subjects (18 years or older).

          -  Previous experience from amplified sound through properly fitted amplification (for
             example but not limited to Hearing aid, Contralateral Routing of Signal (CROS) device,
             Bone conduction hearing device on softband).

          -  Candidate is a fluent speaker in the language used to assess speech perception
             performance.

          -  Willing and able to provide written informed consent

        Exclusion Criteria:

          -  Uncontrolled diabetes as judged by the investigator.

          -  Condition that could jeopardise osseointegration and/or wound healing (e.g.
             osteoporosis, psoriasis, long-term systemic use of corticosteroids) or condition that
             may have an impact on the outcome of the investigation as judged by the investigator.

          -  Insufficient bone quality and quantity to support successful implant placement.

          -  Previous surgery and/or implantation with any bone conduction/active device on the
             side to be implanted, which may jeopardise the implantation and use of the Osia 2
             system, as judged by the investigator.

          -  Use of ototoxic drugs that could be harmful to the hearing, as judged by the
             investigator.

          -  Unable to follow investigational procedures, e.g. to complete quality of life scales,
             or unwilling to comply with the requirements of the clinical investigation as
             determined by the investigator.

          -  Condition with a likely negative progression and/or with expected relapses
             jeopardising general wellbeing and health-related quality of life as judged by the
             investigator.

          -  Subject that has received radiotherapy in the area of implantation or is planned for
             such radiotherapy during the study period.

          -  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 employees of Contract Research Organisations 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 involving an investigational drug or device.
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 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