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| Name | Class |
|---|---|
| Hearts for Hearing | OTHER |
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Overhearing is important for vocabulary learning and speech and language development in young children. However, contemporary hearing aids are generally unable to provide adequate access to low-level auditory inputs from multiple talkers at a distance to capitalize on overhearing. A recent investigation by Jace Wolfe and colleagues showed that, even when aided, children with hearing loss had significantly poorer speech recognition at 40, 50 and 60 dBA compared to children with normal hearing. Furthermore, they showed that increasing hearing aid gain for very low-level inputs produced a statistically significant improvement in syllable-final plural recognition and a non-significant trend toward better monosyllabic word recognition at very low presentation levels. Additional research is needed to document low-level speech recognition ability of children with hearing loss as well as the potential benefit or detriment of increasing hearing aid gain for low-level inputs. A novel hearing aid technology known as Soft Speech Enhancer has been shown improve low-level speech perception in adults with hearing loss; however, the effect of Speech Enhancer on speech recognition in children is not yet known and will be evaluated.
The primary objective of this study is to evaluate whether soft speech recognition in quiet is significantly improved with Speech Enhancer (SE) "on" at the default setting (moderate) compared to Speech Enhancer "off" in children with moderate (N3) to severe (N5) hearing loss. There are several secondary objectives: 1) To evaluate the main effects of age and Speech Enhancer strength, and potential interaction on speech recognition and comfort in children with moderate to severe hearing loss. 2) To demonstrate that hearing aids compensate for hearing loss in children.
This confirmatory clinical investigation will be executed at Hearts for Hearing. It is a single-group, single blind intervention study with each participant serving as his or her own control. However, in certain conditions participant blinding is not feasible (i.e., aided versus unaided performance). The outcome measures being assessed include: speech recognition in quiet with Consonant-Nucleus-Consonant (CNC) words, and comfort ratings using a Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) procedure and looped sentences overlaid with low-level transient noise.
Four different hearing aid conditions will be assessed in this clinical investigation: unaided (no amplification), aided with SE "off", aided with SE "moderate", aided with SE "strong". For the unaided or no treatment condition no hearing aids will be worn. For aided conditions, experienced hearing aid users will be fit binaurally with investigational devices matching their personal device form factor connected to their personal acoustic coupling (e.g., earmold). Using the Audioscan Verifit 2, probe microphone measurements will be conducted to match DSL 5.0 pediatric quiet and noise targets. Three distinct programs will be created, each with a different SE strength.
Hearing aid program order (speech enhancer settings) will be randomized for all testing conditions except for CNC at 50 dBA Quiet with SE Off; that condition is administered first to establish candidacy for further testing. A randomized list of SE settings was generated for all participants for the remaining conditions.
Testing will be completed in a double-walled sound booth with calibrated equipment. Recorded stimuli will be presented through loudspeakers (Sony CFD-ZW755) from clinical audiometers (Grayson Stadler Standard) or Dell computers using the Arizona State University Speech Recognition Program, Windows Media Player and Adobe Audition. Speech stimuli will be presented from a loudspeaker located at 0 degrees azimuth (directly in front).
Speech recognition results will be compared to determine the effect of amplification on accuracy scores as well as the influence of speech enhancer on behaviorally measured benefit and subjectively-derived listening preference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with Hearing Loss | Experimental | Participants age 5-12 with hearing loss who will be fit with study hearing aids and tested on speech perception in unaided and aided condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phonak Audeo P or Naida P hearing aid | Device | Commercially available hearing aid that has access to speech enhancer feature settings "off", "moderate" and "strong" |
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists | One word list of 25 words is presented at 50 dB (quiet conditions) through a front speaker. The percent correctly repeated words are calculated and a higher score indicates better speech perception. The participants completed this task without hearing aids. Data was collected on both age groups, but analysis was completed only on the entire group as a whole. Age effects were not tested. | Day 1 of 1 day study |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings of Speech Enhancer | Participants will listen to a sound sample of looped sentences overlaid with low-level transient noise with the Speech Enhancer at different settings (off, moderate, strong) and rate their preference. An A/B comparison will be used to compare Speech Enhancer Off vs. Speech Enhancer Moderate, and Speech Enhancer Off vs. Speech Enhancer Strong. Participants answered three questions: 1) Which sounds better?, 2) Which is more comfortable?, and 3) Which do you prefer? Results will be reported as qualitative data and no statistical analysis will take place. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hearts for Hearing | Oklahoma City | Oklahoma | 73120 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hearing Impaired Users | Hearing impaired children, age 5 -12 years who are fit with either Audeo P or Naida P and complete all testing requirements (unaided, aided with SE off, aided with SE on moderate, and aided with SE on strong). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who were enrolled in study and were fit with the study hearing aids.
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| ID | Title | Description |
|---|---|---|
| BG000 | Children With Hearing Loss, Age 5-12 | Participants age 5-12 with hearing loss who will be fit with study hearing aids and tested on speech perception in all four required conditions: Unaided, Aided with SE off, Aided with SE moderate, and Aided with SE strong. Phonak Audeo P or Naida P hearing aid: Commercially available hearing aid that has access to speech enhancer feature settings "off", "moderate" and "strong" |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists | One word list of 25 words is presented at 50 dB (quiet conditions) through a front speaker. The percent correctly repeated words are calculated and a higher score indicates better speech perception. The participants completed this task without hearing aids. Data was collected on both age groups, but analysis was completed only on the entire group as a whole. Age effects were not tested. | Hearing impaired participants who completed all required testing conditions: 1) word recognition unaided, 2)word recognition at 40 dB input with SE off, 3) word recognition at 40 dB input with SE on moderate setting, 4) word recognition at 40 dB input with SE on strong setting, 5) word recognition at 50 dB input with SE off, 6) word recognition with at 50 dB input with SE on moderate setting, and 7) word recognition with 50 dB input with SE on strong setting. | Posted | Mean | Standard Deviation | percentage of correctly repeated words | Day 1 of 1 day study |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children With Hearing Loss | Participants age 5-12 with hearing loss who will be fit with study hearing aids and tested on speech perception in unaided and aided condition. Phonak Audeo P or Naida P hearing aid: Commercially available hearing aid that has access to speech enhancer feature settings "off", "moderate" and "strong" |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Neumann, AuD | Hearts For Hearing | 405-548-4300 | sara.neumann@heartsforhearing.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2023 | Nov 27, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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One group of participants will be assessed unaided and aided with Phonak Audeo P or Phonak Naida P hearing aids with Speech Enhancer "off", "on at moderate", and "on at strong" settings.
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Participants will be "blind" as to whether the Speech Enhancer feature is activated or deactivated.
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| Day 1 of 1 day study |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Hearing Impaired Children Age 5-12 |
Hearing impaired children, age 5 -12 years who are fit with either Audeo P or Naida P and tested in all four required conditions: unaided condition at 50 dB, and aided condition with SE off, on at moderate, and on at strong at 40 and 50 dB. |
|
|
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| Secondary | Subjective Ratings of Speech Enhancer | Participants will listen to a sound sample of looped sentences overlaid with low-level transient noise with the Speech Enhancer at different settings (off, moderate, strong) and rate their preference. An A/B comparison will be used to compare Speech Enhancer Off vs. Speech Enhancer Moderate, and Speech Enhancer Off vs. Speech Enhancer Strong. Participants answered three questions: 1) Which sounds better?, 2) Which is more comfortable?, and 3) Which do you prefer? Results will be reported as qualitative data and no statistical analysis will take place. | All participants who completed the testing requirements and were able to provide answers to all three questions: 1) Which sounds better? 2) Which is more comfortable? and 3) Which do you prefer? Data was collected on both age groups, but was analysis was completed only on entire group as a whole. Age effects were not analyzed. | Posted | Count of Participants | Participants | Day 1 of 1 day study |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| SE Off sounds better than SE Moderate |
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| SE Moderate is more comfortable than SE Off |
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| SE Moderate is the same comfort as SE Off |
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| SE Off is more comfortable than SE Moderate |
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| Prefer SE Moderate to SE Off |
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| Prefer both SE Off and SE Moderate the same |
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| Prefer SE Off to SE Moderate |
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| SE Strong sounds better than SE Off |
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| SE Strong sounds the same as SE Off |
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| SE Off sounds better than SE Strong |
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| SE Strong is more comfortable than SE Off |
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| SE Strong is the same comfort as SE Off |
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| SE Off is more comfortable than SE Strong |
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| Prefer SE Strong to SE Off |
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| Prefer both SE Strong and SE Off the same |
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| Prefer SE Off to SE Strong |
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