Hearing ImpairmentNCT04469946
Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)
A study testing Oticon OpenSound Navigator speech enhancement algorithm in people with Hearing Impairment and Sensorineural Hearing Loss, Bilateral, 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 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Impairment, Sensorineural Hearing Loss, Bilateral
- What is being tested?
- Oticon OpenSound Navigator speech enhancement algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 30 Sep 2018
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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: Short-Term Pediatric Acclimatization to Adaptive Hearing Aid Technology
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. The study used a within-subjects design with pre- and post-comparisons involving fifteen pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging from the mild to moderately-severe degree. All participants were fit with bilateral Oticon OPN™ behind-the-ear hearing aids set with the OSN algorithm enabled. The investigators evaluated hearing aid benefit through word recognition in noise (behavioral testing) and everyday hearing/listening abilities (parental/legal guardian reported) within one week of the hearing aid fitting (pre-intervention) and two months post fitting (post-intervention).
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 used a within-subjects study design with pre- and post-comparisons. All participants were fit with bilateral Oticon OPN™ behind-the-ear hearing aids 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 6 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 (pre-intervention) and two months post fitting (post-intervention).
- Being tested
- Oticon OpenSound Navigator speech enhancement 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.
| Study group | Role | What they receive |
|---|---|---|
| Exploratory | Experimental | Participants were fit with Oticon OPN™ behind-the-ear hearing aids with the OpenSound Navigator algorithm enabled. Pre-intervention measures were obtained within one week of the hearing aid fit and post-intervention measures were obtained after two months of daily hearing aid use. Receives: Device: Oticon OpenSound Navigator speech enhancement algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word Recognition in Noise Abilities
Aided speech perception in noise was evaluated using a novel word recognition in noise test. Recorded target word intensity was fixed at 65 decibels (dB) sound pressure level (SPL) with an adaptive noise level set at an initial level of 55 dB SPL. Participants were instructed to keep their head still, listen closely to the target word and repeat the word back. If the repeated word was correct, the noise level increased by 4 dB, if incorrect, the noise reduced by 4 dB. After the second reversal, the adaptive noise level changed to 2 dB increments. This continued for six more noise level reversals for an overall signal-to-noise ratio (SNR) threshold calculation. The final threshold score indicates the estimated SNR level in which the participant correctly recognizes monosyllabic words 50% of the time (SNR-50). This test was performed within a week of hearing aid fitting and again after two months.
Measured: 2 months
Word Recognition in Quiet Abilities
Aided speech perception in quiet was evaluated within a week of hearing aid fitting and again after two months. Recorded sentences were presented at 50 dB SPL, and scoring was based on accuracy of each recited word.
Measured: 2 months
Memory
Long-term vocabulary memory and episodic memory were evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Picture Vocabulary test and the Picture Sequence Memory Test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
Measured: 2 months
Executive Function
Executive function was evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Flanker Inhibitory Control and Attention test and and the Dimensional Change Card Sort test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
Measured: 2 months
Mathematic Academic Performance
Mathematic skills were evaluated using a standardized battery called the Woodcock-Johnson IV Test of Achievement (WJ-IV). Subtests included Applied Problems and Calculation. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
Measured: 2 months
Academic Language Performance
Language skills were evaluated using WJ-IV. Subtests included Letter-Word Identification and Passage Comprehension. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
Measured: 2 months
Secondary outcomes (2)
Speech, Spatial Qualities of Hearing Scale (SSQ) Scores
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, was completed by parents/legal guardian within a week of the hearing aid fitting and after wearing the study hearing aids for two 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: 2 months
Glasgow Hearing Aid Benefit Profile Scores
Glasgow Hearing Aid Benefit Profile, a survey utilizing an ordinal scale with regard to perceived hearing aid benefit was completed by parents/legal guardians within a week of the hearing aid fit and after two months of hearing aid use. It includes 24 questions assessing change in hearing disability, handicap, hearing aid use, benefit and satisfaction and residual (aided) disability relative to the benefit of their previous hearing aids. Each question uses a scale ranging from -100 (reduced benefit) to +100 (increased benefit) with all questions averaged to make a final numeric score.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start5 Mar 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Pediatric hearing aid users (6 to 12 years old) participated in an intervention trial of a hearing aid with an integrated directionality and noise reduction program. Pre- to post-comparison measures were obtained after two months of intervention use.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Moore, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469946
- Sponsor's protocol ID
- 2017-5953-2
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Pediatric Acclimatization to Adaptive Hearing Aid Technology
- ClinicalTrials.gov ID
- NCT04469946
- Acronym / sponsor ID
- 2017-5953-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 14 Jul 2020 (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. The study used a within-subjects design with pre- and post-comparisons involving fifteen pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging from the mild to moderately-severe degree. All participants were fit with bilateral Oticon OPN™ behind-the-ear hearing aids set with the OSN algorithm enabled. The investigators evaluated hearing aid benefit through word recognition in noise (behavioral testing) and everyday hearing/listening abilities (parental/legal guardian reported) within one week of the hearing aid fitting (pre-intervention) and two months post fitting (post-intervention).
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 used a within-subjects study design with pre- and post-comparisons. All participants were fit with bilateral Oticon OPN™ behind-the-ear hearing aids 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 6 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 (pre-intervention) and two months post fitting (post-intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pediatric hearing aid users (6 to 12 years old) participated in an intervention trial of a hearing aid with an integrated directionality and noise reduction program. Pre- to post-comparison measures were obtained after two months of intervention use.
| Arm | Type | Receives |
|---|---|---|
| Exploratory | Experimental | Device: Oticon OpenSound Navigator speech enhancement algorithmParticipants were fit with Oticon OPN™ behind-the-ear hearing aids with the OpenSound Navigator algorithm enabled. Pre-intervention measures were obtained within one week of the hearing aid fit and post-intervention measures were obtained after two months of daily hearing aid use. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
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 | Exploratory |
Primary outcome
Word Recognition in Noise Abilities
Time frame: 2 months
Aided speech perception in noise was evaluated using a novel word recognition in noise test. Recorded target word intensity was fixed at 65 decibels (dB) sound pressure level (SPL) with an adaptive noise level set at an initial level of 55 dB SPL. Participants were instructed to keep their head still, listen closely to the target word and repeat the word back. If the repeated word was correct, the noise level increased by 4 dB, if incorrect, the noise reduced by 4 dB. After the second reversal, the adaptive noise level changed to 2 dB increments. This continued for six more noise level reversals for an overall signal-to-noise ratio (SNR) threshold calculation. The final threshold score indicates the estimated SNR level in which the participant correctly recognizes monosyllabic words 50% of the time (SNR-50). This test was performed within a week of hearing aid fitting and again after two months.
Word Recognition in Quiet Abilities
Time frame: 2 months
Aided speech perception in quiet was evaluated within a week of hearing aid fitting and again after two months. Recorded sentences were presented at 50 dB SPL, and scoring was based on accuracy of each recited word.
Memory
Time frame: 2 months
Long-term vocabulary memory and episodic memory were evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Picture Vocabulary test and the Picture Sequence Memory Test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
Executive Function
Time frame: 2 months
Executive function was evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Flanker Inhibitory Control and Attention test and and the Dimensional Change Card Sort test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
Mathematic Academic Performance
Time frame: 2 months
Mathematic skills were evaluated using a standardized battery called the Woodcock-Johnson IV Test of Achievement (WJ-IV). Subtests included Applied Problems and Calculation. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
Academic Language Performance
Time frame: 2 months
Language skills were evaluated using WJ-IV. Subtests included Letter-Word Identification and Passage Comprehension. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.
2 secondary outcomes
Speech, Spatial Qualities of Hearing Scale (SSQ) Scores
Time frame: 2 months
Glasgow Hearing Aid Benefit Profile Scores
Time frame: 2 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 14 Jul 2020.
- 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 in people with Hearing Impairment and Sensorineural Hearing Loss, Bilateral, 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 14 Jul 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?
Word Recognition in Noise Abilities (time frame: 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020.