Laser Assisted Myringotomy
DESCRIPTION
Myringotomy describes the technique used to create a temporary opening in the tympanic membrane without the insertion of a pressure-equalizing tube (PET). Tympanostomy describes the technique used to create an opening in the tympanic membrane in conjunction with the insertion of a PET. A PET insertion is usually indicated for continuous middle ear aeration for individuals with chronic otitis media with effusion (OME). Myringotomies can be used to acutely decompress the OME affected ear and thus relieve pain. Fluid can also be withdrawn during the procedure to assess for antibiotic needs.
The use of laser-assisted myringotomy is being investigated as an alternative to conventional myringotomy or tympanostomy with tube insertion. This procedure can be performed in the physician's office on anyone older than 6 months of age using only local anesthesia. The eardrum is usually anesthetized using a topical anesthesia. A video monitor is used to pinpoint the exact location for the hole. The precise location for the hole is programmed into the computer, and a CO2 laser creates a small, bloodless opening (1.0 - 3.0 mm) in the tympanic membrane. The procedure takes approximately five minutes once the ear drops have taken effect. The opening usually heals within 3-6 weeks and is normally undetectable afterwards.
POLICY
Laser-assisted myringotomy is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
It has not been demonstrated in the current scientific literature that laser-assisted myringotomy is as effective as preferred standard treatment with conventional myringotomy or tympanostomy with tube insertion. Well-designed, randomized, controlled studies are needed to evaluate laser-assisted myringotomy.
SOURCES
American Academy of Family Physicians (AAFP); American Academy of Otolaryngology - Head and Neck Surgery; American Academy of Pediatrics Subcommittee on Otitis Media With Effusion. (2004). Otitis media with effusion. Pediatrics. 113 (5), 1412 - 1429.
American Academy of Otolaryngology-Head and Neck Surgery. (2010) Ear Tubes. Retrieved July 2, 2010 from: http://www.entnet.org/HealthInformation/Ear-Tubes.cfm.
American Academy of Otolaryngology-Head and Neck Surgery. (2010) Fact Sheet: Why do children have earaches? Retrieved July 2, 2010 from: http://www.entnet.org/HealthInformation/childrensEaraches.cfm.
BlueCross BlueShield Association. Medical Policy Reference Manual. (5:2007). Laser assisted myringotomy and tympanostomy (2.01.36). Retrieved July 2, 2010 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Laser procedure (NCD 140.5, p. 2-67). The Ingenix Complete Guide to Medicare Coverage Issues.
Koopman, J., Reuchlin, A. Kummer, E., Boumans, L., Rijntjes, E., Hoeve, L., et al. (2004). Laser myringotomy versus ventilation tubes in children with otitis media with effusion: A randomized trial. The Laryngoscope, 114 (5), 844 - 849. (Level 1 Evidence)
National Guideline Clearinghouse. National Collaborating Centre for Women’s and Children’s Health. (2008 February). Surgical management of otitis media with effusion in children. Retrieved July 2, 2008 from: http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=14314&string=myringotomy.
Rosenfeld, R., Brown, L., Cannon,C., Dolor, R., Ganiats, T., Hannley, M., et al. (2006). Clinical practice guideline: acute otitis externa. Otolaryngology Head and Neck Surgery, 134 (4 Suppl), S4 - S23.
Rosenfeld, R., Culpepper, L., Doyle, K., Grundfast, K., Hoberman, A., Kenna, M., et al. (2004). Clinical practice guideline: Otitis media with effusion. Otolaryngology Head and Neck Surgery, 130 (5 Supp), S 95 - S 118.
U.S. Food and Drug Administration. (2004, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K040234. Retrieved July 2, 2010 from: http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040234.pdf.
U.S. Food and Drug Administration. (2006, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062369. Retrieved July 2, 2010 from: http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062369.pdf.
U.S. Food and Drug Administration. (2008, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K080463. Retrieved July 2, 2010 from: http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080463.pdf.
U.S. Food and Drug Administration. (2009, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091534. Retrieved July 2, 2010 from: http://www.accessdata.fda.gov/cdrh_docs/pdf9/K091534.pdf.
ORIGINAL EFFECTIVE DATE: 6/1/2000
MOST RECENT REVIEW DATE: 8/12/2010
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