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Escaneo 3D versus molde convencional del oído externo en la fabricación de audífonos: un ensayo controlado
Martin Mølhave1,2, Magnus Madsen1, Line Meier Degnbol3
1Department of Otorhinolaryngology, Head & Neck Surgery, Gødstrup Hospital, Gødstrup, Denmark.
Objective:
To assess whether earmolds manufactured from digital 3D ear scans for hearing aids are non-inferior to earmolds manufactured from conventional silicone impressions in terms of patient satisfaction, self-reported problems, and hearing-aid use.
Design:
A randomised, within-participant ear-level non-inferiority trial was conducted at a public hearing clinic. Each participant received one earmold manufactured from a digital 3D ear scan and one conventionally manufactured earmold, assigned randomly to either ear. The primary outcome was patient-reported satisfaction using a 7-point Likert scale at one and six months. Seventy-six adult patients (152 ears) requiring bilateral closed earmolds were enrolled and followed for six months.
Results:
Both earmold types achieved high satisfaction scores at one and six months, with no significant differences in overall satisfaction. Conventional earmolds showed slightly higher satisfaction for appearance and fit at one month. Self-reported problems and hearing aid usage were similar between groups. A high non-inclusion rate (89%) may limit generalisability.
Conclusions:
Earmolds manufactured from digital 3D ear scans are a clinically viable alternative to conventional impressions for patients who can be successfully scanned, with comparable satisfaction, safety, and usage. However, implementation was constrained by operational barriers and scan failures, which should be addressed to support broader clinical use.
