Hearing ImpairmentOtiSNCT03771287
Hearing Aid Noise Reduction in Pediatric Users (Oticon Study)
A study testing Oticon OpenSound Navigator speech enhancement algorithm and Oticon omni-directional microphone algorithm in people with Hearing Impairment and Hearing Loss, Sensorineural, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of OpenSound Navigator (OSN), a hearing aid speech-enhancement algorithm developed by Oticon, as treatment for pediatric hearing aid users. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Impairment, Hearing Loss, Sensorineural
- What is being tested?
- Oticon OpenSound Navigator speech enhancement algorithm and Oticon omni-directional microphone algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children ages 6 to 13 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
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Learning to Listen in Noise: A Double-blind Randomized Control Trial of a New Hearing Aid Noise Reduction System
The purpose of this study is to evaluate the efficacy of OpenSound Navigator (OSN), a hearing aid speech-enhancement algorithm developed by Oticon, as treatment for pediatric hearing aid users. Using a double-blind experimental design, the investigators aim to compare two treatment groups of pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging from the mild to moderately-severe degree. One group will be fit with bilateral Oticon OPN™ behind-the-ear hearing aids set with an omni-directional microphone setting. The other group will be fit with the same hearing aid model with the OSN algorithm enabled. Participants from the groups will be age and audiogram-matched. The investigators will evaluate hearing aid benefit through word recognition in noise (behavioral testing) and everyday hearing/listening abilities (parental/legal guardian reported) at hearing aid fitting and 6-8 months post fitting.
Read the detailed description
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.
- Conditions
- Hearing Impairment, Hearing Loss, Sensorineural
- Being tested
- Oticon OpenSound Navigator speech enhancement algorithm, Oticon omni-directional microphone algorithm
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oticon OpenSound Navigator speech enhancement algorithmDevice
Also called OSN
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.
Oticon omni-directional microphone algorithmDevice
Also called omni-directional mic
Omni-directional microphone setups come standard for all Oticon hearing aid models. The hearing microphones have equal sensitivity across all directions.
| Study group | Role | What they receive |
|---|---|---|
| OpenSound Navigator (OSN) Hearing Aid | Experimental | 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. Receives: Device: Oticon OpenSound Navigator speech enhancement algorithm |
| omni-directional Hearing Aid | Active comparator | 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. Receives: Device: Oticon omni-directional microphone algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Word Recognition Abilities at 6 to 8 Months
Aided speech perception in noise within a week of hearing aid fitting and again 6-8 months later.
Measured: 6-8 months
Secondary outcomes (2)
Change from Baseline Speech, Spatial Qualities of Hearing Scale (SSQ) Scores at 6 to 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.
Measured: 6-8 months
Hearing aid use time
Average daily use of hearing aids.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start5 Dec 2018
- Primary completion30 Jul 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Oticon
- Responsible party
- Sponsor
- Investigators
- David R Moore, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771287
- Sponsor's protocol ID
- 2017-5953
- Acronym
- OtiS
- Status last verified
- Jan 2020
- First submitted
- 27 Nov 2018
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stewart HJ, Cash EK, Pinkl J, Nakeva von Mentzer C, Lin L, Hunter LL, Moore DR; CCHMC Division of Audiology. Adaptive Hearing Aid Benefit in Children With Mild/Moderate Hearing Loss: A Registered, Double-Blind, Randomized Clinical Trial. Ear Hear. 2022 Sep-Oct 01;43(5):1402-1415. doi: 10.1097/AUD.0000000000001230. Epub 2022 Jun 27.
PubMed 35758427
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning to Listen in Noise: A Double-blind Randomized Control Trial of a New Hearing Aid Noise Reduction System
- ClinicalTrials.gov ID
- NCT03771287
- Acronym / sponsor ID
- OtiS / 2017-5953
- Conditions
- Hearing Impairment, Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Oticon
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of OpenSound Navigator (OSN), a hearing aid speech-enhancement algorithm developed by Oticon, as treatment for pediatric hearing aid users. Using a double-blind experimental design, the investigators aim to compare two treatment groups of pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging from the mild to moderately-severe degree. One group will be fit with bilateral Oticon OPN™ behind-the-ear hearing aids set with an omni-directional microphone setting. The other group will be fit with the same hearing aid model with the OSN algorithm enabled. Participants from the groups will be age and audiogram-matched. The investigators will evaluate hearing aid benefit through word recognition in noise (behavioral testing) and everyday hearing/listening abilities (parental/legal guardian reported) at hearing aid fitting and 6-8 months post fitting.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OpenSound Navigator (OSN) Hearing Aid | Experimental | Device: Oticon OpenSound Navigator speech enhancement algorithmParticipants 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. |
| omni-directional Hearing Aid | Active comparator | Device: Oticon omni-directional microphone algorithmParticipants 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. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- children ages 6 to 13 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oticon OpenSound Navigator speech enhancement algorithmAlso: OSNOpenSound 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. | Device | OpenSound Navigator (OSN) Hearing Aid |
| Oticon omni-directional microphone algorithmAlso: omni-directional micOmni-directional microphone setups come standard for all Oticon hearing aid models. The hearing microphones have equal sensitivity across all directions. | Device | omni-directional Hearing Aid |
Primary outcome
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.
2 secondary outcomes
Change from Baseline Speech, Spatial Qualities of Hearing Scale (SSQ) Scores at 6 to 8 Months
Time frame: 6-8 months
Hearing aid use time
Time frame: 6-8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Derived from this study: PubMed 35758427Stewart HJ, Cash EK, Pinkl J, Nakeva von Mentzer C, Lin L, Hunter LL, Moore DR; CCHMC Division of Audiology. Adaptive Hearing Aid Benefit in Children With Mild/Moderate Hearing Loss: A Registered, Double-Blind, Randomized Clinical Trial. Ear Hear. 2022 Sep-Oct 01;43(5):1402-1415. doi: 10.1097/AUD.0000000000001230. Epub 2022 Jun 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Moore, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oticon OpenSound Navigator speech enhancement algorithm and Oticon omni-directional microphone algorithm in people with Hearing Impairment and Hearing Loss, Sensorineural, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Word Recognition Abilities at 6 to 8 Months (time frame: 6-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03771287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.