Clinical trial NCT05067751: Asymmetrical Directionality With Bimodal Systems.
Official title: Evaluating the Effectiveness of Asymmetrical Directionality With Bimodal Systems.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss
Lead sponsor: GN Hearing A/S
Sponsor class: INDUSTRY
First posted: 2021-10-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects, male/female with diagnosed hearing loss that have been treated with Cochlear implants in one ear.

Brief 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.

Detailed description: The primary purpose of this research trial is to evaluate asymmetrical directionality in bimodal users for hearing speech in noise in the sound field and in daily life using an EMA tool. The aim is to collect information regarding hearing for speech in background noise as well as end-user insights, testimonials, and communication content.

Eligibility criteria: Inclusion Criteria:

Subjects must meet the inclusion criteria described below to be eligible for this clinical investigation.

1. Adults who are English speaking and aged 18 years and older.
2. Individuals with a mild sloping to severe/profound hearing loss in the hearing aided ear.
3. New and experienced bimodal users (cochlear implant + hearing aid).
4. Experienced Nucleus 7 or Kanso 2 cochlear implant users with minimum experience using electrical hearing for 6 months.
5. Individuals able to complete test measures as outlined in the informed consent and protocol.
6. 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.
7. Individuals willing to use their personal email account for participation in the trial.

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Exclusion Criteria:

Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical investigation.

1. Individuals using sound processors in the Hybrid mode.
2. Bilateral cochlear implant users.
3. Unable or unwilling to comply with the requirements of the study as determined by the Investigator.
4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
5. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational device.

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Primary outcomes:
measure: Hearing loss assessed by the SSQ 12 hearing related questionnaire
timeFrame: 2 weeks
Secondary outcomes:
measure: Hearing loss assessed by the AZ Bio sentence test in the presence of noise
timeFrame: 2 weeks
Other outcomes:
measure: Hearing loss will be assessed by using ecological momentary assessments to get a repeated sampling of their behaviors and experiences in real time.
timeFrame: 1 week
Locations:
Study officials:
affiliation: GN Hearing
name: Megan Quilter
role: PRINCIPAL_INVESTIGATOR
References: