Overview
Long-term follow-up of unilateral microtia patients implanted with AUR-201.
Description
Long-term follow-up study of unilateral microtia patients who participated in Study AUR-201-05 and had the AUR-201 implant in place at the final visit (24 weeks post-implantation).
Eligibility
Inclusion Criteria:
- Participated in Study AUR-201-05 and had the AUR-201 implant (auricle* or auricle and wedge) in place at the Final Study Visit of Study AUR-201-05 (24 weeks after the first implantation surgery). *If the Principal Investigator (PI) opted not to implant the wedge component beneath the auricle component and the subject has only the auricle in place at the Final Study Visit of Study AUR-201-05, the subject will be considered eligible under this inclusion criterion;
- Subject or guardian signed the informed consent form (ICF).
Exclusion Criteria:
- Any condition which, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study.
