The purpose of this proposal is to develop an automated Auditory Brainstem Response (ABR) based neurological screening device and software module that will enhance the early detection of autism and other neurological conditions. Autism Spectrum Disorders (ASD) have an incidence rate of 1:68. Based on 3.94 million births in the United States in 2016, 57,941 new cases of ASD will be diagnosed from that birth cohort alone. The practice of early screening and identification of ASD is encouraged by the nation's Healthy People 2020 objectives and the American Academy of Pediatrics. Recent publications have indicated ABR peak latency anomalies associated with ASD. In the United States, approximately 2 million babies per year are currently screened for hearing impairment with ABR technology, one million with Intelligent Hearing Systems (IHS) equipment alone. Current screening protocols use moderate auditory stimulation levels, 35 dB nHL, to focus on hearing sensitivity. A pilot study conducted by the investigators of this proposal showed a significant latency prolongation of ABR peak V in the left ear of 21 newborns diagnosed with ASD when tested at birth during routine hearing screening. The proposed system will add a high stimulation rate supra-threshold testing level necessary for neurological evaluation, and will introduce only one additional minute to the hearing screening process. This additional measure would provide important information regarding a newborn's neurological status at almost no additional cost by capitalizing on current ABR hearing screening protocols and equipment. A special response analysis technique, Continuous Loop Averaging Deconvolution (CLAD), and an automated peak identification algorithm will be implemented in the proposed device. During Phase I, the feasibility of the proposed technology will be evaluated by comparing ABR recordings from 30 ASD children and 30 age-matched control children. In Phase II, a more comprehensive study will be conducted to optimize the proposed device and obtain normative data at high stimulation rates from a broad range of infants and children.

Public Health Relevance

The implementation of the proposed neurological screening system and module with emphasis on ASD will greatly impact public health, at a minimum cost when performed as part of current ABR-based hearing screening protocols, by providing early identification of infants at risk. Early intervention provides a significant opportunity to improve the outcomes of these individuals.

Agency
National Institute of Health (NIH)
Institute
National Institute on Deafness and Other Communication Disorders (NIDCD)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DC018430-01
Application #
9617333
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Miller, Roger
Project Start
2019-08-15
Project End
2020-07-31
Budget Start
2019-08-15
Budget End
2020-07-31
Support Year
1
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Intelligent Hearing Systems
Department
Type
DUNS #
154870455
City
Miami
State
FL
Country
United States
Zip Code
33143