Asymmetrical Directionality With Bimodal Systems.

• Conditions: Hearing Loss

• Registration Number: NCT05067751
• Lead Sponsor: GN Hearing A/S

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.

Study Timeline

• Study First Submitted: 2021-09-21
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-04
• Last Update Submitted: 2021-10-04
• Study First Posted: 2021-10-05
• Last Update Posted: 2021-10-05
• Study Start: 2021-10-06
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hearing loss assessed by the SSQ 12 hearing related questionnaire	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Hearing loss assessed by the AZ Bio sentence test in the presence of noise	2 weeks	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.