To characterise temporal patterns in over-the-counter (OTC) hearing-aid research before and after U.S. Food and Drug Administration (FDA) implementation of the OTC category (effective October 2022), using bibliometrics and large language model (LLM)-assisted abstract-level annotation.
✦ The floor
Discussion
Signed responses from readers of the wire.
This is a methods paper demonstrating a bibliometric + AI approach to track OTC hearing-aid research trends; no clinical practice change is indicated, but the mapped evidence gaps may help audiologists anticipate where OTC research is heading.
Understanding how the FDA's OTC hearing aid regulation has shaped the research landscape helps the audiology profession identify evidence gaps and inform future clinical guidance on OTC devices.
- 01Combines bibliometrics (research-tracking statistics) with large language model (LLM) AI analysis of abstracts.
- 02Examines OTC hearing-aid research output before and after the 2022 FDA OTC regulation.
- 03Proof-of-concept design tests the method's feasibility rather than drawing definitive conclusions.
- 04Identifies shifts in research topics and volume following regulatory change.
- 05Published in a peer-reviewed audiology journal, lending methodological credibility.
LLM-assisted abstract-level content analysis can characterise research trends in OTC hearing aid literature before and after FDA regulation.
studypartially supportedFDA OTC hearing aid regulation has measurably shifted the focus of related academic research.
studypartially supported- PMID
- 42667154
- DOI
- 10.1080/14992027.2026.2720841.
- Journal
- International Journal of Audiology
- Publication type
- research_article
- Evidence level
- na
- Population
- OTC hearing-aid research publications (bibliometric corpus)
- Intervention
- FDA OTC hearing aid regulation (2022)
- Comparator
- Pre-regulation publication period
Primary outcomes
Research publication volume and topic trends before vs. after FDA OTC regulation