Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation

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.

• A newly developed prototype device for speech-evoked EFR Measurement (Device): Speech-evoked envelope following responses (EFRs) are measured using the newly developed clinical prototype to objectively assess auditory responses. Surface electrodes are placed on the head, a non-sense speech stimulus is presented at an average level, and EFRs are recorded for 15-30 minutes while patient sleeps or is at rest.

Primary outcomes

• Speech-Evoked Envelope Following Responses (EFRs) Agreement with Hearing Assessment [Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.]: EFR detection rates will be compared to hearing assessment results for the "Infants with normal hearing" and the "Infants with hearing loss" group for the unaided recording condition. Correlation and regression analysis will be used to look at agreement between prototype measures and the child's hearing assessment results.

Secondary outcomes

• Speech-evoked Envelope Following Response (EFR) Amplitude in Infants with Hearing Loss [Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.]: EFR amplitudes will be compared between the aided and unaided conditions of the "Infants with hearing loss" group. Repeated measures ANOVA and post-hoc paired t-tests will be used for data analysis.
• Speech-Evoked Envelope Following Responses (EFRs) Amplitude Between Normal Hearing and Hearing Loss Infants [Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.]: EFR amplitudes will be compared between the "Infants with normal hearing" and the "Infants with hearing loss" groups. EFR amplitude will also be compared between groups by deriving a normal range of measurement (from normal hearing infants) and characterizing whether measures from infants with hearing loss are or are not within that range. This is a descriptive, not inferential, analysis that is mainly used to aid in interpretation of the nature of the response, so inferential statistics are not proposed.
• Speech-evoked Envelope Following Response (EFR) detection rates in Infants with Hearing Loss [Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.]: EFR detection rates will be compared between the aided and unaided conditions of the "Infants with hearing loss" group. Repeated measures ANOVA and post-hoc paired t-tests will be used for data analysis.
• Speech-Evoked Envelope Following Responses (EFRs) Detection Rate Between Normal Hearing and Hearing Loss Infants [Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.]: EFR detection rate will be compared between the "Infants with normal hearing" and the "Infants with hearing loss" groups. EFR detection rate will also be compared between groups by deriving a normal range of measurement (from normal hearing infants) and characterizing whether measures from infants with hearing loss are or are not within that range. This is a descriptive, not inferential, analysis that is mainly used to aid in interpretation of the nature of the response, so inferential statistics are not proposed.

Sex: All, ages: 3 Months to 24 Months, accepts healthy volunteers

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.

• Easwar V, Scollie S, Lasarev M, Urichuk M, Aiken SJ, Purcell DW. Characteristics of Speech-Evoked Envelope Following Responses in Infancy. Trends Hear. 2021 Jan-Dec;25:23312165211004331. doi: 10.1177/23312165211004331. PMID 34251887
• Easwar V, Purcell DW, Aiken SJ, Parsa V, Scollie SD. Evaluation of Speech-Evoked Envelope Following Responses as an Objective Aided Outcome Measure: Effect of Stimulus Level, Bandwidth, and Amplification in Adults With Hearing Loss. Ear Hear. 2015 Nov-Dec;36(6):635-52. doi: 10.1097/AUD.0000000000000199. PMID 26226606

• Susan Scollie, PhD, Principal investigator, Western University
• David Purcell, PhD, Principal investigator, Western University