UnknownNot Applicable

Asymmetrical Directionality With Bimodal Systems.

10 participantsStarted 2021-10-06

Plain-language summary

Research supports that bimodal stimulation includes improvements in auditory performance and daily living over using a cochlear implant (CI) or hearing aid (HA) alone. Although bimodal users continue to achieve high levels of satisfaction, speech perception in noise continues to be highly problematic. The aim of this field study is to identify which directionality schemes in a bimodal solution are preferred by users using an ecological momentary assessment tool.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adults who are English speaking and aged 18 years and older.
. Individuals with a mild sloping to severe/profound hearing loss in the hearing aided ear.
. New and experienced bimodal users (cochlear implant + hearing aid).
. Experienced Nucleus 7 or Kanso 2 cochlear implant users with minimum experience using electrical hearing for 6 months.
. Individuals able to complete test measures as outlined in the informed consent and protocol.
. Individuals with access to a Smart Phone/device that is either iOS 7.0 or Android 4.0 and later who are willing to utilize their personal Smart Phone/device for participation in the trial.
. Individuals willing to use their personal email account for participation in the trial.

Exclusion criteria

. Individuals using sound processors in the Hybrid mode.
. Bilateral cochlear implant users.
. Unable or unwilling to comply with the requirements of the study as determined by the Investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hearing loss assessed by the SSQ 12 hearing related questionnaire

Timeframe: 2 weeks

Trial details

NCT IDNCT05067751

SponsorGN Hearing A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-11-30

Contact for this trial

Megan E Quilter

13124157270 mquilter@gnresound.com

View on ClinicalTrials.gov More Hearing Loss trials