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Behavioural Intervention

Children with Hearing Loss for Sensorineural Hearing Loss (SoftSpeech Trial)

N/A
Waitlist Available
Research Sponsored by Sonova AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
native English speakers who communicate verbally
no known speech language disorders, cognitive or learning issues
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 of 1 day study
Awards & highlights

SoftSpeech Trial 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.

Eligible Conditions
  • Sensorineural Hearing Loss
  • Bilateral Hearing Loss

SoftSpeech Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

SoftSpeech Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 of 1 day study
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of 1 day study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists
Secondary outcome measures
Subjective Ratings of Speech Enhancer

SoftSpeech Trial Design

1Treatment groups
Experimental Treatment
Group I: Children with Hearing LossExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phonak Audeo P or Naida P hearing aid
2022
N/A
~40

Find a Location

Who is running the clinical trial?

Hearts for HearingUNKNOWN
4 Previous Clinical Trials
135 Total Patients Enrolled
Sonova AGLead Sponsor
78 Previous Clinical Trials
1,831 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~12 spots leftby Mar 2025