Audiobooks for Hearing Loss App as Auditory Training
Hearing Loss · Hearing Impaired Children · Hearing Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04231396 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Audiobooks for hearing loss App (Other)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- BioSpeech
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test |
5.978; 5.889; 5.757; 5.600; 5.398; 5.088 | .037 sig |
| SECONDARY Audiobooks Positive Responses: Percentage of Positive Responses to Final Usability Survey Question: Would You Buy or Recommend Audiobooks for HL App as Auditory Training |
77 | — |
| SECONDARY Audiobooks Adherence: Overall Mean Score of Weekly Goals Met for HA and CI Users Using the Audiobooks for HL App as an Auditory Training Program |
.9275; .9667; .9545; .9420; .9815 | — |
Summary
Eligibility Criteria
Inclusion Criteria
*Because of the COVID-19 Pandemic and low enrollment numbers for certain HL subgroups in the study, the effectiveness of the Audiobooks for Hearing Loss App was measured for the overall group.
Participants had to fall into one of the following five HL subgroups: (1) Adults with HA, moderate HL (41-55 dB); (2) Adults with HA, moderately-severe to severe HL (56 to 90 dB); (3) Adults with non-recent CI, post-lingually deaf; (4) Children, ages 9+, non-recent CI, pre-lingually deaf; and (5) Adults and Children, ages 9+, recent CI, post-lingually deaf. These five subgroups span broad ranges in terms of: (1) age (adults vs. children); (2) severity of hearing loss; (3) device used (HAs vs. Cis); (4) familiarity with device (recent vs. longer-term); and (5) onset of HL (pre-lingual vs. post-lingual. The team expects the highest efficacy for children and adults with recent CI who are post-lingually deaf; the lowest efficacy for adults with HA with either moderate of severe HL; and intermediate efficacy for children with non-recent CI who are pre-lingually deaf.
- speaking English as first language,
- and being able to read at least a first-grade level.
Exclusion Criteria
- no suspicions of cognitive deficits or vision impairments that would interfere with system usage or invalidate usability assessment,
- no signs of external ear disease,
- and all participants will be tested with the Expressive One-Word Picture Vocabulary Test, 4th Edition (EOWPVT-4; Brownell 2000), normed for ages of 2 and older, and are required to score in the 15th percentile or better.
Data sourced from ClinicalTrials.gov (NCT04231396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.