Evaluating the Safety and Usability of an Over-the-Counter Medical Device for Adults With Mild to Moderate Hearing Loss: Formative and Summative Usability Testing
Notice bibliographique
Résumé
Background: Only 15% of the nearly 30 million Americans with hearing loss use hearing aids, partly due to high cost, stigma, and limited access to professional hearing care. Hearing impairment in adults can lead to social isolation and depression and is associated with an increased risk of falls. Given the persistent barriers to hearing aid use, the Food and Drug Administration issued a final rule to allow over-the-counter hearing aids to be sold directly to adult consumers with perceived mild to moderate hearing loss at pharmacies, stores, and online retailers without seeing a physician or licensed hearing health care professional. Objective: We evaluated the safety and usability of an over-the-counter hearing aid prior to Food and Drug Administration approval and market release. Methods: We first conducted a formative usability test of the device and associated app with 5 intended users to identify outstanding safety and usability issues (testing round 1). Following design modifications, we performed a summative usability test with 15 intended users of the device (testing round 2). We concurrently conducted a test with 21 nonintended users (ie, users with contraindications to use) to ascertain if consumers could determine when they should not use the device, based on the packaging, instructions, and labeling (testing round 3). Participants were asked to complete 2-5 tasks, as if they were using the hearing aid in real life. After each task, participants rated the task difficulty. At the end of each session, participants completed a 10-question knowledge assessment and the System Usability Scale and then participated in debriefing interviews to gather qualitative feedback. All sessions were video recorded and analyzed to identify use errors and design improvement opportunities. Results: Usability issues were identified in all 3 usability testing rounds. There were minimal safety-related issues with the device. Round 1 testing led to several design modifications which then increased task success in round 2 testing. Participants had the most difficulty with the task of pairing the hearing aids to the cell phone. Participants also had difficulty distinguishing the right and left earbuds. Nonintended users did not always understand device contraindications (eg, tinnitus and severe hearing loss). Overall, test findings informed 9 actionable design modifications (eg, clarifying pairing steps and increasing font size) that improved device usability and safety. Conclusions: This study evaluated the usability and safety of an over-the-counter hearing aid for adults with mild to moderate hearing loss. Human factors engineering methods identified opportunities to improve the safety and usability of this direct-to-consumer medical device for individuals with perceived mild-moderate hearing loss.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,035 | 0,063 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,001 | 0,000 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».