Asymmetrical Directionality With Bimodal Systems.

NCT05067751 | Unknown

• 1 other identifier: Parker
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Hearing loss assessed by the SSQ 12 hearing related questionnaire

  Speech Spatial and Qualities of hearing questionnaire is designed to measure of range of hearing disabilities across several domains. Specific attention is given to hearing speech in a host of competing contexts, and to the directional, distance and movement components of spatial hearing.

  2 weeks

Secondary Outcomes (1)

• Hearing loss assessed by the AZ Bio sentence test in the presence of noise

  2 weeks

Other Outcomes (1)

• Hearing loss will be assessed by using ecological momentary assessments to get a repeated sampling of their behaviors and experiences in real time.

  1 week

Interventions

hearing aid with directionality DEVICE

Hearing directionality allows users the ability to focus on voices and other signals of interest, reducing background noises that are unimportant.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects, male/female with diagnosed hearing loss that have been treated with Cochlear implants in one ear.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational device.

Sponsors & Collaborators

• GN Hearing A/S: lead

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Megan Quilter

  GN Hearing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan E Quilter

CONTACT

13124157270; mquilter@gnresound.com

Bryan McDonald

CONTACT

303-472-4061; bmcdonald@cochlear.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 5, 2021
• Study Start: October 6, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share