Hearing Aid Noise Reduction in Pediatric Users (Oticon Study) (OtiS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03771287|
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : December 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hearing Impairment Hearing Loss, Sensorineural||Device: Oticon OpenSound Navigator speech enhancement algorithm Device: Oticon omni-directional microphone algorithm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double-blinded randomized control trial of OpenSound Navigator (OSN) enabled/disabled hearing aids. Only the fitting audiologist will know if the OSN algorithm is enabled or disabled in the research hearing aids. Will be un-blinded after data collection is complete in order to carry out group comparison analysis.|
|Official Title:||Learning to Listen in Noise: A Double-blind Randomized Control Trial of a New Hearing Aid Noise Reduction System|
|Actual Study Start Date :||December 5, 2018|
|Actual Primary Completion Date :||July 30, 2020|
|Actual Study Completion Date :||August 30, 2020|
Experimental: OpenSound Navigator (OSN) Hearing Aid
Participants will be fit with Oticon OPN™ behind-the-ear hearing aids with the OpenSound Navigator algorithm enabled. Participants are to use the hearing aids at least an average of 8 hours per day over the course of 6-8 months.
Device: Oticon OpenSound Navigator speech enhancement algorithm
OpenSound Navigator (OSN) is a speech enhancement algorithm developed by Oticon. The feature is built in Oticon's current OPN™ hearing aid platform and can be adjusted and disabled in the programming. It is designed to automatically enhance speech while reducing unwanted background noise to improve communication for the user.
Other Name: OSN
Active Comparator: omni-directional Hearing Aid
Participants will be fit with Oticon OPN™ behind-the-ear hearing aids with the Omni-directional microphone system enabled. Participants are to use the hearing aids at least an average of 8 hours per day over the course of 6-8 months.
Device: Oticon omni-directional microphone algorithm
Omni-directional microphone setups come standard for all Oticon hearing aid models. The hearing microphones have equal sensitivity across all directions.
Other Name: omni-directional mic
- Change from Baseline Word Recognition Abilities at 6 to 8 Months [ Time Frame: 6-8 months ]Aided speech perception in noise within a week of hearing aid fitting and again 6-8 months later.
- Change from Baseline Speech, Spatial Qualities of Hearing Scale (SSQ) Scores at 6 to 8 Months [ Time Frame: 6-8 months ]Speech, Spatial and Qualities of Hearing Scale (SSQ), a survey utilizing an ordinal scale specifically measuring hearing aid benefit with regard to speech understanding, spatial awareness, perceptual quality of sound, and conversation, will be completed by parents/legal guardian within a week of the hearing aid fitting and after wearing the study hearing aids for 6-8 months. There are 4 survey sections. Section A: Speech has 8 questions, Section B: Spatial Hearing has 5 questions, Section C: Qualities of Hearing has 8 questions and Section D: Conversational Uses of Hearing has 5 questions. Each question uses a scale ranging from 0 (poorest possible outcome) to 100 (best possible outcome). Each section calculates an average score across the corresponding questions for a total of 4 individual scores.
- Hearing aid use time [ Time Frame: 6-8 months ]Average daily use of hearing aids.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771287
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||David R Moore, Ph.D.||Children's Hospital Medical Center, Cincinnati|