Osia CPT Code Study

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    20
  • sponsor
    Cochlear
Updated on 25 January 2021
deafness

Summary

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

Details
Condition Mixed conductive and sensorineural hearing loss, Conductive hearing loss, mixed hearing loss
Treatment Osia 2 system
Clinical Study IdentifierNCT04320407
SponsorCochlear
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Mixed conductive and sensorineural hearing loss or Conductive hearing loss?
Do you have any of these conditions: Conductive hearing loss or mixed hearing loss or Mixed conductive and sensorineural hearing loss?
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note