Abstract / Summary
Tympanic membrane perforation is a common otologic disorder. In cases where spontaneous closure does not occur, or when the perforation is associated with clinically significant symptoms that adversely affect quality of life, surgical repair is often indicated. This review and meta-analysis aimed to synthesize and critically appraise the current evidence on the use of human amniotic membrane (HAM) as a graft material in tympanoplasty. A systematic literature search was conducted in multiple databases for studies published up to November 2025. The following search terms were used in titles and abstracts (with corresponding MeSH terms applied in PubMed): "Amnion" OR "Placenta" AND "Tympanoplasty." Single-arm meta-analysis using a random effects model was performed to assess improvement in the air-bone gap (ABG) and anatomical closure rates. Standardized methodological criteria were applied to assess study quality and risk of bias. Out of 630 identified records, eight studies evaluating 265 tympanoplasties (264 patients) using amniotic membrane grafting (AMG) were included. The majority of non-randomized studies carried a serious risk of bias. A single-arm meta-analysis of 4 studies demonstrated a pooled complete anatomical closure rate of 92% (95% CI 0.79-0.98; I2 = 44.1%). Functional assessment via single-arm meta-analysis of 4 studies showed a statistically non-significant pooled mean difference in air-bone gap (ABG) improvement of 12.66 dB (95% CI-0.22 to 25.54), though between-study heterogeneity was high (I2 = 99.4%). Operative times for AMG ranged widely across 2 reporting studies, but one comparative study noted significantly shorter times for AMG compared to temporalis fascia grafting (54.3 vs. 75.3 min). Postoperative graft failure rates were low, primarily driven by sparse instances of infection or graft lateralization. Publication bias could not be formally assessed due to the small number of included studies. HAM is a promising alternative to conventional graft material with excellent anatomical closure, improved but non-significant ABG, and lower operative times. Although current findings support HAM as a viable alternative to conventional grafts in tympanoplasty, the predominance of non-randomized studies, small sample sizes, and methodological heterogeneity constrain the strength of the conclusions. High-quality, adequately powered RCTs are required to better define the optimal indications, techniques, and long-term outcomes associated with HAM use in middle ear surgery.