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NCT05527730
Clinical Trial Evaluating Outcomes of Self-Fit and Professionally Fit Hearing Aids
NA trial testing Comparison of PRO-FIT or SELF-FIT fitting in Hearing Loss in 80 participants. Status unknown.
10 December 2022
Quick facts
| Lead sponsor | Whisper.ai |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 80 |
| Start date | 7 July 2022 |
| Primary completion | 10 December 2022 |
| Estimated completion | 20 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Comparison of PRO-FIT or SELF-FIT fitting
Conditions studied
- Hearing Loss — all drugs for Hearing Loss →
Sponsor
Whisper.ai
Who can join
Adults 18 to 80, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Approximately 48 million people in the United States have hearing loss or hearing difficulties in noisy environments. Whisper.ai Inc has previously brought to market a commercial hearing aid system that reduces background noise and amplifies voices and sounds of interest using its proprietary platform based on machine learning and artificial intelligence technologies. Whisper.ai Inc now seeks to bring to market a new hearing system that will incorporate a "self-fitting" capability. Self-fitting hearing aids have emerged in recent years as a potentially viable option to calibrate hearing aids to the needs of individual users without clinician intervention. The purpose of this project is to evaluate the efficiency and reliability of the fitting procedure and algorithms developed by Whisper.ai Inc. The study will be carried out using a randomized crossover design in two phases: in phase 1, subjects will be tested and a hearing aid will be fitted using conventional audiological standard procedures , and in phase 2, the subject will be tested and a hearing aid will be fitted using the results of the self-fitting algorithm. Objective, subjective, and behavioral responses will be gathered from a variety of hearing-related surveys and tests, and will be analyzed quantitatively to evaluate the efficiency and reliability of the self-fitting algorithm. The investigators expect the fitting results of the Whisper.ai self-fitting algorithm to be similar to those of standardized fitting procedures conducted by hearing professionals.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05527730
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Related trials
Other recruiting trials for Hearing Loss
Currently open trials in the same condition.
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- NCT07414329 — Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit · NA · recruiting
- NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05527730 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Whisper.ai
- Last refreshed: 7 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05527730.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing