Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418321
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-15
Brief Title:
Early Identification of Age-related Hearing Impairment
Sponsor:
Aalto University
Organization:
Aalto University
Study Overview
Official Title:
Early Identification of Age-related Hearing Impairment
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The need for future hearing rehabilitation is enormous World Health Organization WHO 2021 has estimated that by 2050 25 billion people will have some degree of hearing loss and 14 of them will require hearing rehabilitation Currently healthcare systems and processes are already overwhelmed and not adequately equipped to screen and diagnose this rapidly growing population suffering from hearing impairment This study aims to investigate if the diagnostics of age-related hearing loss can be accelerated by involving patients in the hearing assessment process
Detailed Description:
The investigational device used in the study is part of the Otoscreen hearing screening system that is developed by Aalto University
The investigational device consists of the following parts
Digital otoscope
User interface control unit
The investigational device is designed to record high-quality images and videos of the eardrum and ear canal and guide users through a hearing screening test while collecting data from questionnaires digital otoscopy and audiometry
The investigational device is used together with a CE-marked audiometer that is intended for hearing screening testing
The investigational device consists of the following parts
Digital otoscope
User interface control unit
The investigational device is designed to record high-quality images and videos of the eardrum and ear canal and guide users through a hearing screening test while collecting data from questionnaires digital otoscopy and audiometry
The investigational device is used together with a CE-marked audiometer that is intended for hearing screening testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None