Viewing Study NCT04040517



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Last Modification Date: 2024-10-26 @ 1:15 PM
Study NCT ID: NCT04040517
Status: UNKNOWN
Last Update Posted: 2019-07-31
First Post: 2019-05-21

Brief Title: Auditory Steady State Response vsAuditory Brainstem Response
Sponsor: Assiut University
Organization: Assiut University

Study Overview

Official Title: ASSR in Hearing Impaired Children With Absent ABR Waves
Status: UNKNOWN
Status Verified Date: 2019-07
Last Known Status: NOT_YET_RECRUITING
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: All children with hearing loss should have access to resources necessary to reach their maximum potential The following principles provide the foundation for effective EHDIEarly Hearing Detection Intervention systems and have been updated and expanded since the 2000 JCIH joint Committee on Infant Hearing position statement
Detailed Description: 1 All infants should have access to hearing screening using a physiologic measure at no later than 1 month of age
2 All infants who do not pass the initial hearing screening and the subsequent rescreening should have appropriate audiological and medical evaluations to confirm the presence of hearing loss at no later than 3 months of age
3 All infants with confirmed permanent hearing loss should receive early intervention services as soon as possible after diagnosis but at no later than 6 months of age A simplified single point of entry into an intervention system that is appropriate for children with hearing loss is optimal

The importance of early identification and habilitation of hearing loss for improved access to auditory stimuli and for positive prognosis of speech and language is well established in the literature Auditory brain stem response ABR is the most commonlly used test in clinical practice to estimate the degree of hearing loss but the auditory brainstem response ABR cannot differentiate between severe and profound SNHL 5 whereas the ASSR can provide threshold information in a frequency-specific manner at intensity levels of 120 dB and higher This intensity stimulation advantage uniquely qualifies the ASSR for investigation of residual hearing in young and difficult-to-test cochlear implant candidates

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