Asymmetrical Directionality With Bimodal Systems.

Evaluating the Effectiveness of Asymmetrical Directionality With Bimodal Systems.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Device: hearing aid with directionality

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.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Megan E Quilter; Phone Number: 13124157270; Email: mquilter@gnresound.com
• Study Contact Backup: Name: Bryan McDonald; Phone Number: 303-472-4061; Email: bmcdonald@cochlear.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing loss assessed by the AZ Bio sentence test in the presence of noise	AZ Bio sentence in noise test comprised of 15 lists of 20 sentences each and is a measure of speech perception ability by individuals that mimics real life conditions with the presence of background noise.	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing loss will be assessed by using ecological momentary assessments to get a repeated sampling of their behaviors and experiences in real time.	Ecological momentary assessment will act as a digital diary, in real time, to understand subject's real life behaviors in their momentary environments.	1 week

Collaborators and Investigators

• Sponsor: GN Hearing A/S
• Investigators: Principal Investigator: Megan Quilter, GN Hearing

Study record dates

Study Major Dates

• Study Start (Anticipated): October 6, 2021
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: Parker

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No