Hearing Aid Noise Reduction in Pediatric Users (Oticon Study)

OpenSound Navigator (OSN) is a speech enhancement hearing aid algorithm developed by Oticon
that utilizes an adaptive directional microphone system with an automatic gain control noise
reduction program. This hearing aid feature is intended for adult hearing aid users and its
potential benefits of speech, vocabulary and listening development in pediatric users has not
been investigated. Here the investigators aim to evaluate the efficacy of OSN programming in
pediatric hearing aid users (6-12 years of age) diagnosed with a symmetrical sensorineural
hearing loss in the mild to moderately-severe range. The investigators will use a
double-blind randomized control methodology of two participant matched (based on age and
audiometric configuration) groups. The first group will include pediatric patients fit with
bilateral Oticon OPN™ behind-the-ear hearing aids with the standard Omni-directional
microphone setting enabled. Group two will include pediatric patients fit with the same
hearing aid model with the OSN feature enabled. Participants will undergo standard
audiometric diagnostic testing and will be fit with the hearing aids by a licensed clinical
audiologist. Participants are required to wear the hearing aids full time (at least 8 hours
per day average) during the duration of the study. The evaluation measures will include
speech recognition testing in controlled background noise and the Speech, Spatial and
Qualities of Hearing Scale questionnaire (completed by parents/legal guardian). Testing will
be performed within a week of the hearing aid fitting and 6-8 months post fitting.

Inclusion Criteria:

- children ages 6 to 12 years

- English as the primary home language

- positive for bilateral symmetrical mild to moderately-severe sensorineural hearing
loss

- currently using hearing aids that were dispensed at least 18 months prior to
enrollment of the study

- negative for major cognitive handicap or developmental delay that would prevent or
restrict participation, as determined by the PI or designee

- negative for learning disability, for example attention-deficit/hyperactivity
disorder, as determined by the PI or designee

- negative for serious neurological or psychiatric disease that would prevent or
restrict participation, as determined by the PI or designee

- informed consent of parent/guardian

- assent of participating child if aged 11 years and over

- standard MRI inclusion criteria as set by the Cincinnati Children's Hospital Medical
Center department of Radiology

- not currently pregnant or breast feeding

- willingness and ability of the participant and/or the participant's caregiver to
comply with study requirements

- no history of medical neglect of caregiver