Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation

The goal of this study is to evaluate the sensitivity of a newly-developed prototype device in its ability to measure brain responses to speech sounds in an infant population. The main research questions are: 1) Is the prototype sensitive to brain response differences from infants with hearing loss with and without hearing aids? and 2) How do the measured brain responses from infants with hearing loss compare to infants with normal hearing who are the same age? Participants will have their brain responses measured using the prototype in response to average-level non-sense speech sounds across 1 to 2 sessions in a "no-hearing aids" condition. Participants with hearing loss who are already fit with hearing aids will additionally undergo a "with hearing aids" recording condition.

In addition to the listed collaborator sites under the "sponsors and collaborators" section, this study is conducted in collaboration with the National Acoustic Laboratories (NAL), Australia, who serve as an international clinical research site contributing to data collection and scientific expertise in pediatric audiology. The prototype is being provided by Audioscan, Dorchester, ON, Canada. Additionally, the newly developed clinical prototype device is not a U.S. FDA-regulated device. ClinicalTrials.gov registration is being completed as a prerequisite for Health Canada's investigational testing of medical devices, as outlined in Health Canada's 2007 Notice concerning registration and public disclosure of clinical trial information. The application number for Health Canada's investigational testing authorization is 389562.

Inclusion Criteria: 1. Infants (3 to 24 months of age) with normal hearing who have passed their audiological diagnostic evaluation 2. Infants (3 to 24 months of age) identified with hearing loss at their audiological diagnostic evaluation, whose parents have chosen spoken language as their form of communication, and who have been prescribed and fitted with a hearing aid(s). Exclusion Criteria: Participants who have abnormal middle ear measure results or occluding ear wax will be excluded.