Does the EarPopper® device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial

Objective To provide an independent evaluation of the efficacy and safety of the EarPopper® in improving hearing outcomes in children with otitis media with effusion (OME) and reducing the ventilation tube insertion rate. Study Design Randomised single‐blinded controlled trial. Setting The Ear Nose...

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Published in:Clinical otolaryngology 2016-02, Vol.41 (1), p.59-65
Main Authors: Banigo, A., Hunt, A., Rourke, T., Whiteside, O., Aldren, C.
Format: Article
Language:English
Subjects:
Audiology - instrumentation
Child
Child, Preschool
Female
Hearing - physiology
Hearing Loss - therapy
Humans
Male
Otitis Media with Effusion - complications
Otitis Media with Effusion - therapy
Safety
Treatment Outcome
Validation Studies as Topic
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cited_by cdi_FETCH-LOGICAL-c3910-e065ae4d5d4b9668d56da39cd4f7953a0663e3aae3a922b88a602a57607bbc3b3
cites cdi_FETCH-LOGICAL-c3910-e065ae4d5d4b9668d56da39cd4f7953a0663e3aae3a922b88a602a57607bbc3b3
container_end_page 65
container_issue 1
container_start_page 59
container_title Clinical otolaryngology
container_volume 41
creator Banigo, A.
Hunt, A.
Rourke, T.
Whiteside, O.
Aldren, C.
description Objective To provide an independent evaluation of the efficacy and safety of the EarPopper® in improving hearing outcomes in children with otitis media with effusion (OME) and reducing the ventilation tube insertion rate. Study Design Randomised single‐blinded controlled trial. Setting The Ear Nose and Throat Department of a district general hospital (Heatherwood and Wexham Park). Participants and Methods Twenty‐nine children aged between 4 and 11 years diagnosed with persistent OME lasting at least 3 months with an average hearing of 25 dBHL or worse in the better ear were randomised to a treatment or control group for 7 weeks using random computer‐generated codes. Syndromic children, children with developmental delay, previous grommets and cleft palate were excluded. The audiologists were blinded at the final post‐treatment audiogram. Results After the seven‐week period, the mean improvement in air conduction across all frequencies was 10.9 dBHL in the treatment group (P 
doi_str_mv 10.1111/coa.12480
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A randomised single-blinded controlled trial</title><source>Wiley</source><creator>Banigo, A. ; Hunt, A. ; Rourke, T. ; Whiteside, O. ; Aldren, C.</creator><creatorcontrib>Banigo, A. ; Hunt, A. ; Rourke, T. ; Whiteside, O. ; Aldren, C.</creatorcontrib><description>Objective To provide an independent evaluation of the efficacy and safety of the EarPopper® in improving hearing outcomes in children with otitis media with effusion (OME) and reducing the ventilation tube insertion rate. Study Design Randomised single‐blinded controlled trial. Setting The Ear Nose and Throat Department of a district general hospital (Heatherwood and Wexham Park). Participants and Methods Twenty‐nine children aged between 4 and 11 years diagnosed with persistent OME lasting at least 3 months with an average hearing of 25 dBHL or worse in the better ear were randomised to a treatment or control group for 7 weeks using random computer‐generated codes. Syndromic children, children with developmental delay, previous grommets and cleft palate were excluded. The audiologists were blinded at the final post‐treatment audiogram. Results After the seven‐week period, the mean improvement in air conduction across all frequencies was 10.9 dBHL in the treatment group (P &lt; 0.001) and 3.6 dBHL in the control group (P = 0.201). At every frequency, the treatment group had larger improvements in air conduction, the largest being at 4 kHz where the mean air conduction in both ears improved by 14.8 dBHL. Compliance with the EarPopper® was over 90%, the only side‐effect reported being discomfort in the ears immediately after use which resolved and did not affect compliance. The ventilation tube insertion rate was 53.3% in the treatment group and 78.6% in the control group. Median follow‐up time for all patients is 47.7 months. Conclusion Our study shows that the EarPopper® is a safe, effective treatment option for children with hearing loss from persistent OME, and it reduces the rate of ventilation tube insertion. More studies with larger sample sizes are required to support our findings.</description><identifier>ISSN: 1749-4478</identifier><identifier>EISSN: 1749-4486</identifier><identifier>DOI: 10.1111/coa.12480</identifier><identifier>PMID: 26095773</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Audiology - instrumentation ; Child ; Child, Preschool ; Female ; Hearing - physiology ; Hearing Loss - therapy ; Humans ; Male ; Otitis Media with Effusion - complications ; Otitis Media with Effusion - therapy ; Safety ; Treatment Outcome ; Validation Studies as Topic</subject><ispartof>Clinical otolaryngology, 2016-02, Vol.41 (1), p.59-65</ispartof><rights>2015 John Wiley &amp; Sons Ltd</rights><rights>2015 John Wiley &amp; Sons Ltd.</rights><rights>2016 John Wiley &amp; Sons Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3910-e065ae4d5d4b9668d56da39cd4f7953a0663e3aae3a922b88a602a57607bbc3b3</citedby><cites>FETCH-LOGICAL-c3910-e065ae4d5d4b9668d56da39cd4f7953a0663e3aae3a922b88a602a57607bbc3b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26095773$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Banigo, A.</creatorcontrib><creatorcontrib>Hunt, A.</creatorcontrib><creatorcontrib>Rourke, T.</creatorcontrib><creatorcontrib>Whiteside, O.</creatorcontrib><creatorcontrib>Aldren, C.</creatorcontrib><title>Does the EarPopper® device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial</title><title>Clinical otolaryngology</title><addtitle>Clin Otolaryngol</addtitle><description>Objective To provide an independent evaluation of the efficacy and safety of the EarPopper® in improving hearing outcomes in children with otitis media with effusion (OME) and reducing the ventilation tube insertion rate. Study Design Randomised single‐blinded controlled trial. Setting The Ear Nose and Throat Department of a district general hospital (Heatherwood and Wexham Park). Participants and Methods Twenty‐nine children aged between 4 and 11 years diagnosed with persistent OME lasting at least 3 months with an average hearing of 25 dBHL or worse in the better ear were randomised to a treatment or control group for 7 weeks using random computer‐generated codes. Syndromic children, children with developmental delay, previous grommets and cleft palate were excluded. The audiologists were blinded at the final post‐treatment audiogram. Results After the seven‐week period, the mean improvement in air conduction across all frequencies was 10.9 dBHL in the treatment group (P &lt; 0.001) and 3.6 dBHL in the control group (P = 0.201). At every frequency, the treatment group had larger improvements in air conduction, the largest being at 4 kHz where the mean air conduction in both ears improved by 14.8 dBHL. Compliance with the EarPopper® was over 90%, the only side‐effect reported being discomfort in the ears immediately after use which resolved and did not affect compliance. The ventilation tube insertion rate was 53.3% in the treatment group and 78.6% in the control group. Median follow‐up time for all patients is 47.7 months. Conclusion Our study shows that the EarPopper® is a safe, effective treatment option for children with hearing loss from persistent OME, and it reduces the rate of ventilation tube insertion. More studies with larger sample sizes are required to support our findings.</description><subject>Audiology - instrumentation</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Female</subject><subject>Hearing - physiology</subject><subject>Hearing Loss - therapy</subject><subject>Humans</subject><subject>Male</subject><subject>Otitis Media with Effusion - complications</subject><subject>Otitis Media with Effusion - therapy</subject><subject>Safety</subject><subject>Treatment Outcome</subject><subject>Validation Studies as Topic</subject><issn>1749-4478</issn><issn>1749-4486</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><recordid>eNp1kc1u1DAUhSMEoj-w4AWQJTawSOvEjh2v0GjaTpFGLQtQl5Zj3zAuTjzYTksfpS_BQ_BkuKSdBRKWLF_L3zm616co3lT4qMrrWHt1VNW0xc-K_YpTUVLasue7mrd7xUGM1xhTgnn1stirGRYN52S_uD_xEFHaADpV4bPfbiH8_oUM3FgNyA7b4G8AbUAFO35DfkraD5m3I9Ib60yAEd3atEFZFm1MMCbkk002ogGMVfMj9P0UrR8_ogUKajR-sBEMitnSQdk5O5p81X5MwTuXyxSscq-KF71yEV4_nofF17PTL8vzcn25-rRcrEtNRIVLwKxRQE1jaCcYa03DjCJCG9pz0RCFGSNAlMpb1HXXtorhWjWcYd51mnTksHg_--ZZf0wQk8ztaXBOjeCnKKuMCiyyOKPv_kGv_RTG3F2mmqYmXBCaqQ8zpYOPMUAvt8EOKtzJCsuHvGTOS_7NK7NvHx2nLv_YjnwKKAPHM3BrHdz930kuLxdPluWseMjj506hwnfJOOGNvLpYyYvzK3q2Wp_INfkDAhuxYg</recordid><startdate>201602</startdate><enddate>201602</enddate><creator>Banigo, A.</creator><creator>Hunt, A.</creator><creator>Rourke, T.</creator><creator>Whiteside, O.</creator><creator>Aldren, C.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>8FD</scope><scope>FR3</scope><scope>K9.</scope><scope>M7Z</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>201602</creationdate><title>Does the EarPopper® device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial</title><author>Banigo, A. ; Hunt, A. ; Rourke, T. ; Whiteside, O. ; Aldren, C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3910-e065ae4d5d4b9668d56da39cd4f7953a0663e3aae3a922b88a602a57607bbc3b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Audiology - instrumentation</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Female</topic><topic>Hearing - physiology</topic><topic>Hearing Loss - therapy</topic><topic>Humans</topic><topic>Male</topic><topic>Otitis Media with Effusion - complications</topic><topic>Otitis Media with Effusion - therapy</topic><topic>Safety</topic><topic>Treatment Outcome</topic><topic>Validation Studies as Topic</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Banigo, A.</creatorcontrib><creatorcontrib>Hunt, A.</creatorcontrib><creatorcontrib>Rourke, T.</creatorcontrib><creatorcontrib>Whiteside, O.</creatorcontrib><creatorcontrib>Aldren, C.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Biochemistry Abstracts 1</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical otolaryngology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Banigo, A.</au><au>Hunt, A.</au><au>Rourke, T.</au><au>Whiteside, O.</au><au>Aldren, C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Does the EarPopper® device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial</atitle><jtitle>Clinical otolaryngology</jtitle><addtitle>Clin Otolaryngol</addtitle><date>2016-02</date><risdate>2016</risdate><volume>41</volume><issue>1</issue><spage>59</spage><epage>65</epage><pages>59-65</pages><issn>1749-4478</issn><eissn>1749-4486</eissn><abstract>Objective To provide an independent evaluation of the efficacy and safety of the EarPopper® in improving hearing outcomes in children with otitis media with effusion (OME) and reducing the ventilation tube insertion rate. Study Design Randomised single‐blinded controlled trial. Setting The Ear Nose and Throat Department of a district general hospital (Heatherwood and Wexham Park). Participants and Methods Twenty‐nine children aged between 4 and 11 years diagnosed with persistent OME lasting at least 3 months with an average hearing of 25 dBHL or worse in the better ear were randomised to a treatment or control group for 7 weeks using random computer‐generated codes. Syndromic children, children with developmental delay, previous grommets and cleft palate were excluded. The audiologists were blinded at the final post‐treatment audiogram. Results After the seven‐week period, the mean improvement in air conduction across all frequencies was 10.9 dBHL in the treatment group (P &lt; 0.001) and 3.6 dBHL in the control group (P = 0.201). At every frequency, the treatment group had larger improvements in air conduction, the largest being at 4 kHz where the mean air conduction in both ears improved by 14.8 dBHL. Compliance with the EarPopper® was over 90%, the only side‐effect reported being discomfort in the ears immediately after use which resolved and did not affect compliance. The ventilation tube insertion rate was 53.3% in the treatment group and 78.6% in the control group. Median follow‐up time for all patients is 47.7 months. Conclusion Our study shows that the EarPopper® is a safe, effective treatment option for children with hearing loss from persistent OME, and it reduces the rate of ventilation tube insertion. More studies with larger sample sizes are required to support our findings.</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>26095773</pmid><doi>10.1111/coa.12480</doi><tpages>7</tpages></addata></record>
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subjects Audiology - instrumentation
Child
Child, Preschool
Female
Hearing - physiology
Hearing Loss - therapy
Humans
Male
Otitis Media with Effusion - complications
Otitis Media with Effusion - therapy
Safety
Treatment Outcome
Validation Studies as Topic
title Does the EarPopper® device improve hearing outcomes in children with persistent otitis media with effusion? A randomised single-blinded controlled trial
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