Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPhonak Audeo P or Naida P hearing aid
Commercially available hearing aid that has access to speech enhancer feature settings off, moderate and strong
Sponsors
Hearts for Hearing
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants will be blind as to whether the Speech Enhancer feature is activated or deactivated.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* native English speakers who communicate verbally * no known speech language disorders, cognitive or learning issues * experienced hearing aid users (\> 6 months use) * full-time hearing aid users (i.e., wear on a daily basis) * CNC word scores of 30% or better at 50dBA in quiet with SE off
Exclusion criteria
* new hearing aid users * inconsistent hearing aid users * \<4 years or \>12 years of age * non-native English speaker who communicates verbally * known cognitive/ learning issues or speech language disorder * CNC word scores \< 30% correct presented at 50dBA in quiet with SE off
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists | Day 1 of 1 day study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Ratings of Speech Enhancer | Day 1 of 1 day study | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Children With Hearing Loss, Age 5-12 | — |
|---|---|---|
| Age, Continuous | 9 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 36 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
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.
Time frame: Day 1 of 1 day study
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hearing Impaired Children Age 5-12 | Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists | Percent words correct unaided, in quiet (50 dBA) | 6.06 percentage of correctly repeated words | Standard Deviation 9.73 |
| Hearing Impaired Children Age 5-12 | Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists | Percent words correct aided with SE off, in quiet ( 40 dBA) | 53.7 percentage of correctly repeated words | Standard Deviation 13.02 |
| Hearing Impaired Children Age 5-12 | Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists | Percent words correct, aided with SE moderate, in quiet (40 dBA) | 66.61 percentage of correctly repeated words | Standard Deviation 11.92 |
| Hearing Impaired Children Age 5-12 | Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists | Percent words correct, aided with SE strong, in quiet (40 dBA) | 69.7 percentage of correctly repeated words | Standard Deviation 12 |
| Hearing Impaired Children Age 5-12 | Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists | Percent words correct, aided SE off, in quiet (50 dBA) | 74.7 percentage of correctly repeated words | Standard Deviation 9.1 |
| Hearing Impaired Children Age 5-12 | Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists | Percent words correct, aided SE moderate, in quiet (50 dBA) | 81.76 percentage of correctly repeated words | Standard Deviation 6.78 |
| Hearing Impaired Children Age 5-12 | Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists | Percent words correct, aided SE strong, in quiet (50 dBA) | 83.76 percentage of correctly repeated words | Standard Deviation 6.87 |
Comparison: An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA .Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE moderate. Analysis of age effects was not completed.p-value: 0.00595% CI: [1.79, 12.99]ANOVA
Comparison: An ANOVA was conducted for the three SE conditions (off, moderate, strong) at 50 dBA . Post -hoc comparisons were done using Bonferroni's correction. Below result is the mean comparison between SE of and SE strong. An analysis of age effects was not completed.p-value: <0.00195% CI: [3.91, 15.11]ANOVA
Comparison: Null hypothesis: There will be no significant differences between the mean unaided CNC score at 50 dBA and the mean aided CNC score with SE off.p-value: <0.001t-test, 2 sided
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.
Time frame: Day 1 of 1 day study
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Moderate sounds better than SE Off | 10 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Moderate sounds the same as SE Off | 16 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Off sounds better than SE Moderate | 6 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Moderate is more comfortable than SE Off | 6 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Moderate is the same comfort as SE Off | 14 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Off is more comfortable than SE Moderate | 12 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | Prefer SE Moderate to SE Off | 12 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | Prefer both SE Off and SE Moderate the same | 12 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | Prefer SE Off to SE Moderate | 8 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Strong sounds better than SE Off | 15 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Strong sounds the same as SE Off | 11 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Off sounds better than SE Strong | 5 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Strong is more comfortable than SE Off | 8 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Strong is the same comfort as SE Off | 17 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | SE Off is more comfortable than SE Strong | 6 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | Prefer SE Strong to SE Off | 16 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | Prefer both SE Strong and SE Off the same | 9 Participants |
| Hearing Impaired Children Age 5-12 | Subjective Ratings of Speech Enhancer | Prefer SE Off to SE Strong | 6 Participants |