Optimizing Soft Speech Recognition in Children With Hearing Loss
Condition: Hearing Loss, Sensorineural; Hearing Loss, Bilateral
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
Study type: Interventional

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.
    

Intervention name(s): Phonak Audeo P or Naida P hearing aid
Intervention type(s): Device
Intervention description(s): Commercially available hearing aid that has access to speech enhancer feature settings "off", "moderate" and "strong"
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment