Clinical trial NCT04040517: Auditory Steady State Response vsAuditory Brainstem Response
Official title: [ASSR] in Hearing Impaired Children With Absent [ABR] Waves
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Impaired Children
Keywords: Hearing Loss
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Evaluate of residual hearing function in hearing impaired children with absent ABR waves and normal middle ear pressure.

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 EHDI\[Early Hearing Detection \& Intervention\] 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.

Eligibility criteria: Inclusion Criteria:

* Absent ABR \[Auditory Breanstem Response\] waves .
* normal middle ear function

Exclusion Criteria:

* Ears with otitis media with effusion,
* Preserved otoacuastic emission ,
* Preserved ABR waves .

Primary outcomes:
measure: A 40 hearing impaired children with absent ABR waves
timeFrame: one year
Secondary outcomes:
measure: After ASSR evaluation for this patient we can take decision either for hearing aid amplification of for (surgery) cochlear implant .
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
citation: Wadhera R, Hernot S, Gulati SP, Kalra V. A controlled comparison of auditory steady-state responses and pure-tone audiometry in patients with hearing loss. Ear Nose Throat J. 2017 Oct-Nov;96(10-11):E47-E52. doi: 10.1177/0145561317096010-1109.