Evaluation of the safety and efficacy of a novel product for the removal of impacted human cerumen

Douglas Fullington, Jenny Song, Antionette Gilles, Xiaowen Guo, Waley Hua, C Eric Anderson, Joseph Griffin, Douglas Fullington, Jenny Song, Antionette Gilles, Xiaowen Guo, Waley Hua, C Eric Anderson, Joseph Griffin

Abstract

Background: This open-label study evaluated the safety and efficacy of a novel product for the removal of impacted cerumen in adult patients.

Methods: This was a prospective, single-center, single-arm, self-controlled clinical trial conducted in a community general practice setting. The novel product contains glycolic acid in an otologically-acceptable buffer containing sodium bicarbonate and glycerin and other buffering agents. The product was instilled into the ear canal prior to irrigation with warm water. Severity of cerumen impaction was graded using a 5-point scale. Improvement in tympanic membrane visualization was assessed after instillation and irrigation.

Results: A majority (83%, 25/30) of ears showed improvement with one application: with 53% (16/30) totally dissolved and gained 100% TM visualization. Total dissolution was observed in 80% (24/30) of the study ears per the intent-to-treat analysis and 86% (24/28) if irrigation instructions were followed. Most of the ears/participants that had cerumen blockage symptoms experienced significant improvement with the application. Feelings of fullness disappeared in 92% (11/12) of the affected ears; ears itching, 91% (10/11); water trapping or cracking, 78%, and decreased hearing disappeared in 71% (10/14). All (100%, 18) of the participants who completed the application satisfaction assessment were satisfied with the application process in terms of time needed and the overall rinse procedure. Only one mild adverse event (ear pruritis) occurred that was related to application.

Conclusions: The tested cerumen removal product was effective and safe for removing moderate to severe blockage in patients with impacted cerumen. Procedure satisfaction for the product was high.

Trial registration: This trial is registered on http://www.clinicaltrials.gov/. The registration number is NCT02829294. The trial was retrospectively registered on July 8, 2016.

Keywords: Cerumen removal; Cerumenolytic; Topical earwax removal.

Figures

Fig. 1
Fig. 1
Cerumen blockage symptoms before and after application with the cerumen-removal product. Pre-application, n = 30 ears. Post-application, n = 28 ears. Significant improvements were observed after application for decreased hearing (P = 0.0209), tinnitus (P = 0.0027), feelings of fullness (P = 0.0325), and ear itching (P = 0.0209)
Fig. 2
Fig. 2
Application satisfaction. n = 18 participants. The application satisfaction assessment was not available for one participant

References

    1. Roland PS, Smith TL, Schwartz SR, Rosenfeld RM, Ballachanda B, Earll JM, et al. Clinical practice guideline: cerumen impaction. Otolaryngol Head Neck Surg. 2008;139(3 Suppl 2):S1–S21. doi: 10.1016/j.otohns.2008.06.026.
    1. Alberti PW. Epithelial migration on the tympanic membrane. J Laryngol Otol. 1964;78:808–30. doi: 10.1017/S0022215100062800.
    1. Roeser RJ, Ballachanda BB. Physiology, pathophysiology, and anthropology/epidemiology of human earcanal secretions. J Am Acad Audiol. 1997;8(6):391–400.
    1. Lewis-Cullinan C, Janken JK. Effect of cerumen removal on the hearing ability of geriatric patients. J Adv Nurs. 1990;15(5):594–600. doi: 10.1111/j.1365-2648.1990.tb01859.x.
    1. Meador JA. Cerumen impaction in the elderly. J Gerontol Nurs. 1995;21(12):43–5. doi: 10.3928/0098-9134-19951201-09.
    1. McCarter DF, Courtney AU, Pollart SM. Cerumen impaction. Am Fam Physician. 2007;75(10):1523–8.
    1. Garahan MB, Waller JA, Houghton M, Tisdale WA, Runge CF. Hearing loss prevalence and management in nursing home residents. J Am Geriatr Soc. 1992;40(2):130–4. doi: 10.1111/j.1532-5415.1992.tb01932.x.
    1. Moore AM, Voytas J, Kowalski D, Maddens M. Cerumen, hearing, and cognition in the elderly. J Am Med Dir Assoc. 2002;3(3):136–9. doi: 10.1016/S1525-8610(04)70455-7.
    1. Kochkin S. Customer satisfaction with hearing instruments in the digital age. Hear J. 2005;58:30–43. doi: 10.1097/01.HJ.0000286545.33961.e7.
    1. Guest JF, Greener MJ, Robinson AC, Smith AF. Impacted cerumen: composition, production, epidemiology and management. QJM. 2004;97(8):477–88. doi: 10.1093/qjmed/hch082.
    1. Raman R. Impacted ear wax--a cause for unexplained cough? Arch Otolaryngol Head Neck Surg. 1986;112(6):679.
    1. Prasad KS. Cardiac depression on syringing the ear. A case report. J Laryngol Otol. 1984;98(10):1013. doi: 10.1017/S0022215100147905.
    1. Paulose KO, Shenoy PK, Sharma RK. Otogenic reflex cough: implanted hair in the bony external auditory canal. Arch Otolaryngol Head Neck Surg. 1988;114(11):1334. doi: 10.1001/archotol.1988.01860230128042.
    1. Yang EL, Macy TM, Wang KH, Durr ML. Economic and demographic characteristics of cerumen extraction claims to Medicare. JAMA Otolaryngol Head Neck Surg. 2016;142(2):157–61. doi: 10.1001/jamaoto.2015.3129.
    1. Pothier DD, Hall C, Gillett S. A comparison of endoscopic and microscopic removal of wax: a randomised clinical trial. Clin Otolaryngol. 2006;31(5):375–80. doi: 10.1111/j.1749-4486.2006.01288.x.
    1. Manchaiah V, Arthur J, Williams H. Does hearing aid use increase the likelihood of cerumen impaction. J Audiol Otol. 2015;19(3):168–71. doi: 10.7874/jao.2015.19.3.168.
    1. Wilson PL, Roeser RJ. Cerumen management: professional issues and techniques. J Am Acad Audiol. 1997;8(6):421–30.
    1. Hand C, Harvey I. The effectiveness of topical preparations for the treatment of earwax: a systematic review. Br J Gen Pract. 2004;54(508):862–7.
    1. Roland PS, Eaton DA, Gross RD, Wall GM, Conroy PJ, Garadi R, et al. Randomized, placebo-controlled evaluation of Cerumenex and Murine earwax removal products. Arch Otolaryngol Head Neck Surg. 2004;130(10):1175–7. doi: 10.1001/archotol.130.10.1175.
    1. Rojahn R. Summaries of nursing care-related systematic reviews from the Cochrane Library: Ear drops for the removal of ear wax. Int J Evid Based Healthc. 2010;8(3):151–2. doi: 10.1111/j.1744-1609.2010.00174.x.
    1. Schmiemann G, Kruschinski C. Complication rate of out-patient removal of ear wax: systematic review of the literature. HNO. 2009;57(7):713–8. doi: 10.1007/s00106-009-1898-z.
    1. Zackaria M, Aymat A. Ear candling: a case report. Eur J Gen Pract. 2009;15(3):168–9. doi: 10.3109/13814780903260756.
    1. Hornibrook J. Where there’s smoke there's fire--ear candling in a 4-year-old girl. N Z Med J. 2012;125(1367):138–40.
    1. Rafferty J, Tsikoudas A, Davis BC. Ear candling: should general practitioners recommend it? Can Fam Physician. 2007;53(12):2121–2.
    1. Bortz JT, Wertz PW, Downing DT. Composition of cerumen lipids. J Am Acad Dermatol. 1990;23(5 Pt 1):845–9. doi: 10.1016/0190-9622(90)70301-W.
    1. Carr MM, Smith RL. Ceruminolytic efficacy in adults versus children. J Otolaryngol. 2001;30(3):154–6. doi: 10.2310/7070.2001.20001.
    1. Jimenez N, Garcia ML, Galan J, Vallet A, Owen GR, Wall GM. Development of a liquid enzyme-based ceruminolytic product. J Pharm Sci. 2008;97(11):4970–82. doi: 10.1002/jps.21337.
    1. Fraser JG. The efficacy of wax solvents: in vitro studies and a clinical trial. J Laryngol Otol. 1970;84(10):1055–64. doi: 10.1017/S0022215100072856.
    1. Kornhauser A, Coelho SG, Hearing VJ. Applications of hydroxy acids: classification, mechanisms, and photoactivity. Clin Cosmet Investig Dermatol. 2010;3:135–42. doi: 10.2147/CCID.S9042.
    1. Wang X. A theory for the mechanism of action of the alpha-hydroxy acids applied to the skin. Med Hypotheses. 1999;53(5):380–2. doi: 10.1054/mehy.1998.0788.
    1. Saxby C, Williams R, Hickey S. Finding the most effective cerumenolytic. J Laryngol Otol. 2013;127(11):1067–70. doi: 10.1017/S0022215113002375.
    1. Burton MJ, Doree C. Ear drops for the removal of ear wax. Cochrane Database Syst Rev. 2009;(1):CD004326.
    1. Burton MJ, Doree CJ. Ear drops for the removal of ear wax. Cochrane Database Syst Rev. 2003;(3):CD004400.
    1. Knebl J, Harty B, Anderson CE, Dean WD, Griffin J. In vitro comparison of three earwax removal formulations for the disintegration of earwax Submitted. 2017
    1. Oron Y, Zwecker-Lazar I, Levy D, Kreitler S, Roth Y. Cerumen removal: comparison of cerumenolytic agents and effect on cognition among the elderly. Arch Gerontol Geriatr. 2011;52(2):228–32. doi: 10.1016/j.archger.2010.03.025.
    1. Robinson AC, Hawke M, MacKay A, Ekem JK, Stratis M. The mechanism of ceruminolysis. J Otolaryngol. 1989;18(6):268–73.
    1. Robinson AC, Hawke M, Naiberg J. Impacted cerumen: a disorder of keratinocyte separation in the superficial external ear canal? J Otolaryngol. 1990;19(2):86–90.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi