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Original Investigation |

Effectiveness of Earplugs in Preventing Recreational Noise–Induced Hearing Loss A Randomized Clinical Trial

Geerte G. J. Ramakers, MD1,2; Véronique J. C. Kraaijenga, MD1,2; Guido Cattani, Bsc1; Gijsbert A. van Zanten, MD, PhD1,2; Wilko Grolman, MD, PhD1,2
[+] Author Affiliations
1Department of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Utrecht, Utrecht, the Netherlands
2Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, the Netherlands
JAMA Otolaryngol Head Neck Surg. 2016;142(6):551-558. doi:10.1001/jamaoto.2016.0225.
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Importance  The incidence of hearing loss has risen in past years. Attendance at music festivals and concerts may contribute to this increasing problem.

Objective  To assess the effectiveness of earplugs in preventing temporary hearing loss immediately following music exposure.

Design, Setting, and Participants  A randomized, single-blind clinical trial was conducted on September 5, 2015, at an outdoor music festival in Amsterdam, the Netherlands. Normal-hearing adult volunteers were recruited via social media. An exclusion criterion was the participants’ intention to wear earplugs. Of the 86 volunteers assessed, 51 were included in the study. All analyses were performed on an intention-to-treat basis.

Interventions  Participants were randomly assigned to a group using earplugs or an unprotected group during a 4½-hour festival visit.

Main Outcomes and Measures  The primary study outcome was a temporary threshold shift (TTS) on the audiogram, primarily for frequencies at 3 and 4 kHz. Secondary study outcomes included distortion product otoacoustic emission (DPOAE) measurements and claims of tinnitus using a questionnaire and tinnitus matching experiments.

Results  Of 51 participants included, 25 were randomized to the earplug group and 26 to the unprotected group. Nine in each group (36% and 35%, respectively) were men, and the mean (SD) ages were 27.3 (5.6) years in the earplug group and 27.0 (6.2) years in the unprotected group. Baseline demographics were similar in both groups. The time-averaged, equivalent A-weighted sound pressure level experienced was 100 dBA during the festival. A TTS over frequencies at 3 and 4 kHz after exposure was seen in 4 of 50 ears (8%) in the earplug group compared with 22 of 52 ears (42%) in the unprotected group (P < .001). The relative risk for a TTS after exposure was 5.3 (95% CI, 2.0-14.3) for the unprotected group vs the earplug group. The number needed to treat with earplugs for preventing 1 TTS was 2.9. The DPOAE amplitudes decreased significantly more over the frequencies 2 to 8 kHz in the unprotected group: the mean (SD) decrease in magnitude was 0.6 (2.8) dB in the earplug group vs 2.2 (1.9) dB in the unprotected group (P = .04). Newly induced tinnitus following sound exposure occurred in 3 of the 25 participants (12%) in the earplug group vs 10 of 25 (40%) in the unprotected group (difference, 28%; 95% CI, 3.6%-49.0%; P = .02).

Conclusions and Relevance  Earplug use is effective in preventing temporary hearing loss after loud music exposure. The present randomized clinical trial adds proof to the scarce evidence and knowledge on this topic, which is a growing global problem.

Trial Registration  trialregister.nl Identifier: NTR5401

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Figure 1.
Flowchart of Participant Pathways

The flowchart shows the exact number of participants during the study process. DPOAE indicates distortion product otoacoustic emission.

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Figure 2.
Distortion Product Otoacoustic Emission (DPOAE) Levels Before and After Music Exposure

The mean DPOAEs for both ears are shown before and after exposure for the earplug and the unprotected group separately. A decrease in mean levels is clear for the unprotected group, whereas DPOAEs for the earplug group do not decrease significantly. SPL indicates sound pressure level.

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