Tucson, Arizona 85718

  • Mixed Hearing Loss

Purpose:

To evaluate the clinical efficacy of the Osia 2 system in patients with conductive or mixed conductive hearing loss in a US cohort.


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


NCT ID:

NCT04320407


Primary Contact:

Principal Investigator
Mark Syms, MD
Arizona Hearing Center

George Cire
Phone: 303 885 5440
Email: gcire@cochlear.com


Backup Contact:

Email: btiernan@cochlear.com
Bridget Tiernan


Location Contact:

Tucson, Arizona 85718
United States

Marjorie Pazzi, B.N., R.N.
Email: mpazzi@neurotucson.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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