Update on first African clinical trial on earpopper for the treatment of otitis media with effusion [FCT/UATH/HREC/PR/330].

Background: Otitis media with effusion (OME) is a middle ear condition characterized by the accumulation of serous fluid. It is common, though not exclusive; among children with its attendant developmental consequence if missed or untreated in early life. OME could be managed surgically, pharmacologically, or physiologically. EarPopper is a medical device developed for physiologic management of OME, Eustachian tube dysfunction, and related problems. We aim to ascertain the suitability/efficiency of EarPopper® device for the treatment of OME in our setting. Methodology: This is a prospective interventional study of volunteers diagnosed with OME from four (4) medical centers in Abuja. Pneumatic otoscopy, video-otoscopy, tympanometry, and pure-tone audiometry were done to confirm the diagnosis. Serial EarPopper sessions were performed twice weekly for 2-12 weeks, and outcome was assessed using patients' reports. The reports include the EarPopper scoring system (ESS) and audiometric parameters (before and after therapy).
Results: Forty-five patients (17 males and 28 females) aged between 3-56 years were enrolled. Thirty-five were diagnosed with bilateral OME and 10 unilateral. All patients had Type-B tympanometry tracing with mild-to-moderate conductive hearing losses and ESS of between 2.45% and 84%. Out of the 45 participants, 32 (71.1%) completed the treatment, whereas 13 (28.9%) were lost to follow-up. Duration of EarPopper treatment ranged from 2 to 12 weeks. The outcome revealed improvement in 26/32 (81.3%) with significant reduction in ESS (1% to 9.8%). Six patients 6/32 (18.9%) had persistence symptoms. These 18.9% had the propensity to progress to chronic OME.
Conclusion: This study highly suggests good prospect in using EarPopper for the management of OME among Africans.

INTRODUCTION

Otitis media with effusion (OME) is a pathological condition associated with the accumulation of nonpurulent mucoid or serous fluid in the middle ear cleft in an intact tympanic membrane. OME, also called mucoid otitis media, glue ear, secretory otitis media, or serous otitis media depending on the consistency of the fluid, results from either Eustachian tube disorder or hyperactivity of the middle ear glands.[1] Every child aged 2 months to 12 years is prone to developing OME.[2] According to the American Academy of Otorhinolaryngology Head and Neck Surgery's Committee on OME, more than 50% of children will suffer from OME within their 1st year of life and over 60% by their second birthday.[2] Downs syndrome, craniofacial abnormalities, or congenital anatomical defects of the nasopharynx are associated with 93% OME prevalence rate, before surgical repairs.[3] It is mainly a childhood disease (85% of cases) and rarely seen in adults.[4] Adenoid enlargement, eustachian tubes (ET) dysfunctions, and atopy are mainly the etiological factors in children,[4] whereas nasopharyngeal tumors, rhinosinusitis, and barotrauma are in adults.[5]

The management of OME could be medical, surgical, or physiological. Medical measures include the administration of decongestants, antihistamines, corticosteroids, and sometimes antibiotics. The benefits of antihistamines and antibiotics have been questioned and/or not recommended for treatment.[2]

Surgical measures may include myringotomy, with or without tympanostomy tube placement, adenoidectomy with or without tonsillectomy. Critics of the surgical method have cited middle ear infections, retraction of tympanic membrane™, recurrence, among others as some of the setbacks associated with the method. The physiological methods are noninvasive procedures hinging on the natural-physiology of maintaining pressure equilibrium and dry middle ear in man, for example, Valsalva maneuver, functional Eustachian tube, and the Politzer principles. The above enumerated methods could serve as adjunct to the management of the OME or definitive on its own. It is necessary to ensure the early resolution of OME to avoid adverse consequences and complications.[6] To this end, there is a need for an inexpensive, efficient, nontraumatic, and least complication-prone method for the management of OME. This led to the development of the EarPopper® which is based on the Politzer physiology principles.[78] It is a medical device that brings about the decongestion of the middle ear cavity through insufflations of the ET. Similarly, a related problem to OME, where the EarPopper therapy could be indicated is the eustachian tube dysfunction.[89] The ascent or descent of the heights can cause serious discomfort which sometimes threaten career prospects. The Valsalva maneuvers and Politzer have been deployed in managing such patients, and sometimes decompression may be necessary. The EarPopper® was also reported to be effective in two other ways (a) resolution of suppurative otitis media by aeration and oxygenation of the anaerobic milieu in the middle ear[810] and (b) serving as an improvised hand-held respirator in respiratory insufficiency-related illnesses.[11]

It has passed through all necessary stages of scrutiny including clinical trials in the USA and finally got the approval of the FDA in 2007.[89] The method appears safe and efficient among users in the USA and Europe but yet to be tested among Africans. Therefore, this study is aimed at assessing the efficiency of EarPopper® device for the treatment of OME in our setting.

METHODOLOGY

A prospective interventional study of volunteers diagnosed with OME from four medical centers in Abuja (registration approval FCT/UATH/HREC/PR/330);

University of Abuja Teaching Hospital, Abuja

Garki Hospital, Abuja

Abuja Clinic, Abuja

Kubwa General Hospital.

A successful pilot study to assess the suitability of the methods and also validate the EarPopper Scoring System (ESS) was conducted in three of the four study centers.[11] Pneumatic otoscopy, video otoscopy, tympanometry, and pure tone audiometry were done to confirm OME on the volunteers before enrollment into the study proper. The criteria for inclusion were (a) clinical evidence of OME, namely, symptoms and otoscopic features; (b) confirmation of OME through Type B tympanogram obtained using Amplaid-tymp model A756; (c) evidence of Conductive Hearing Loss (CHL) with tuning fork and pure tone audiometry using Amplivox 270 model audiometer/ISO calibrated.

The enrollment of patients was through convenient sampling method, and the ethical considerations in line with the Helsinki Declaration were followed. They had serial Ear-Ppopper (model EP-3000) therapies [Figure 5], twice weekly for 2–12 weeks. The outcome was evaluated using patients’ reports, ESS, and the Audiometric Assessment Parameters. Resolution of OME: this refers to a total clearance of effusion within the middle ear which was assessed using a dichotomous variable of “absence” or “presence” of effusion posttreatment and clinical reports. Nonresolution for OME – this refers to a persistence or presence of middle ear effusion after 12 weeks of treatment with ear popper.

Figure 5

Performing the EarPopper procedure

RESULTS

Forty-five patients (17 males and 28 females) aged between 3 and 56 years were enrolled in the study [Table 1]. Thirty-five were diagnosed of bilateral OME and ten were unilateral (80 ears). All the patients had Type B-tympanometry tracing curves with mild-to-moderate CHLs. The pretherapy ESS was between 2.45% and 84% [Table 1]. The duration of the EarPopper therapies ranged from 2 to 12 weeks. Out of the 45 patients that participated, 32 (71.1%) completed the treatment, whereas 13 (28.9%) were lost to follow-up [Tables 1 and 2]. PostEarPopper therapy outcome revealed resolution in seven unilateral cases and twenty bilateral cases (comprising a successful resolution in 47 Ears) out of the 29 bilateral and three unilateral cases (61 ears). One bilateral case had unilateral resolution [Table 2]. The overall percentage OME resolution was 47/60 ears (78.3% success) and 27/32 patients (84.4%).

Tables 1

Pre - and post - therapy EarPopper scoring system

Age (years)	Pretherapy ESS	Posttherapy ESS
25	28.7	3.8
30	60	9.8
54	84	7.5
11	18.4	5.1
17	15	1
45	31	4.1
21	2.45	2
3	22.2	8.4
5	10	2
23	25	2
40	23.8	5
20	67	56
38	54.4	12
20	46	8.5
27	34	3.7
35	46.7	45
22	16.5	2
45	35	35
55	53	49
34	34	34
56	37	13
28	28	2.5
30	39	8
10	23	1.5
42	56	40
20	34	-
37	25	25
21	23	1.5
30	60	25
39	28.5	-
18	45	45
50	34.7	-
52	48	-
40	48	24
43	25	-
32	37	-
30	34	-
55	27	13
24	23	-
38	18.5	-
26	18.5	3.7
36	14.8	-
22	7.4	-
25	7.4	-
23	3.7	-

ESS=EarPopper scoring system

Table 2

Values and outcome of the EarPopper scoring system

Age/years	Sex	Diagnosis	Duration of illness before EP	Duration EP EP treatment	Tympanogram/audiogram
					Pre RX	After Rx
25	Female	Right OME	6 months	3	Type B/moderate CHL	Type AS/mild CHL
30	Male	Bilateral OME	1 year	4	Type B (bilateral)/mild CHL (bilateral)	Type A (right)/normal hearing Type B (left)/mild CHL
54	Male	Bilateral OME	2 years	11	Type B (bilateral)/moderate CHL (bilateral)	Type A (right)/normal hearing Type As (left)/mild CHL
11	Female	Bilateral OME	5 months	3	Type B (bilateral)/mild CHL (bilateral)	Type A (bil)/normal hearing (bilateral)
17	Male	Bilateral OME	13 months	2	Type B (bilateral)/mild CHL (bilateral)	Type A (right)/normal hearing
45	Male	Right OME	3 years	10	Type B (right)/moderate CHL (right)	Type A/mild CHL
21	Female	Bilateral OME	9 months	2	Type B (bilateral)/moderate CHL	Type A (bilateral)/normal hearing (bilateral)
3	Female	Bilateral OME	24 months	3	Type B, mixed hearing loss (mild)	Type A
5	Female	Bilateral OME	3 months	3	Type B, mixed hearing loss (mild)	Type A
23	Female	Bilateral OME	2 weeks	2	Type B, normal PTA	Type A
40	Female	Bilateral OME	2 days	1	Type B, CHL (mild)	Type A
20	Male	Right OME	2 days	4	Type B	Type A
38	Male	Right OME	6 days	1	Type B, CHL (mild)	Type A
20	Female	Left OME	1 week	3 weeks	Type B, CHL (mild)	Type A
27	Female	Bilateral OME	1 week	2 weeks	Type B, mild CHL	Type A
35	Male	Bilateral OME	1 month	2 weeks	Type B, mild CHL	Type A
22	Female	Left OME	1 year	2 weeks	Type B, mild CHL	PTA not done
45	Female	Bilateral OME	6 months	12 weeks	Type B, CHL (mild) bil	Type B,/CHL (mild) bil
55	Female	Bilateral OME	4 years	12 weeks	Type B, CHL (mild) bil	Type B,/CHL (mild) bil
34	Female	Bilateral OME	2 weeks	3 weeks	Type B, CHL (mod)	Type B,/CHL (mod). LTF
56	Male	Bilateral OME	6 months	4 weeks	Type B, CHL (mod)	Type A,/mild HL
28	Male	Bilateral OME	2 weeks	4 weeks	Type B, mild CHL	Type A
30	Female	Bilateral OME	1 month	8 weeks	Type B	Type A
10	Female	Right OME	2 weeks	4 weeks	Type B	Type A
42	Female	Bilateral OME	1 week	1 week	Type B,/severe CHL	Type B,/mild CHL
20	Male	Left OME	3 months	10	Type B,/severe CHL	LTF
37	Female	Bilateral OME	2 months	12	Type B/CHL (moderate)	Type B/CHL (moderate)
21	Female	Bilateral OME	1 month	8 weeks	Type B	Type A
30	Male	Bilateral OME	6 weeks	8 weeks	Type B, mild CHL	Type A
39	Female	Bilateral OME	2 years	1 week	Type B, mild CHL	LTF
18	Male	Bilateral OME	3 years	12 weeks	Type C, moderate CHL	Type B/moderate CHL
50	Female	Bilateral OME	4 months	1 week	Type B	LTF
52	Male	Bilateral OME	8 years	1 week	Type C,/moderate CHL	LTF
40	Female	Bilateral OME	4 years	12 weeks	Type B	Type A
43	Female	Bilateral OME	3 days	1 week	Type B	LTF
32	Female	Bilateral OME	1 week	1 week	Type B	LTF
30	Female	Bilateral OME	2 weeks	1 week	Type B/mild CHL	LTF
55	Male	Bilateral OME	2 weeks	1 week	Type B/mild CHL	Type A
24	Male	Bilateral OME	1 month	1 week	Type B/mild CHL	LTF
38	Female	Bilateral OME	3 months	8 weeks	Type C/CHL (mod)	LTF
26	Male	Bilateral OME	5 years	12 weeks	Type B/CHL (mod)	Type B/mild CHL
36	Male	Bilateral OME	5 days	1 week	Type B	LTF
22	Female	Bilateral OME	1 month	4 weeks	Type B/mild CHL	LTF
25	Female	Right OME	8 months	1 week	Type B/CHL (mod)	LTF
23	Female	Left OME	2 days	1 week	Type B/	LTF

LTF=Lost to follow up, OME=Otitis media with effusion, EP=EarPopper, CHL=Conductive hearing loss, PTA=Pure tone average

The posttherapy ESS dropped significantly; from 2.45%–84% to 1%–9.8%. This is about 240% to 840% significant improvement. Six patients 6/32 (18.9%) had persistence symptoms. These 18.9% had the propensity to progress to chronic OME.

DISCUSSION

The EarPopper [Figure 1] has been successfully tested in young children. Arick and Silman[7] in 2005 carried out a randomized control study on children between 4 and 11 years in the United States of America. The study reported significant improvements with the remarkable recovery of hearing sensitivity. They noted that further studies of safety and effectiveness were required in children younger than 4 years, adolescents, and adults. Our study was aimed at filling in the gap by including both children and adults. Many episodes of OME resolve spontaneously within 3 months, but about 30% to 40% of children have recurrent OME and 5% to 10% of episodes past 1 year or longer.[2] Forty-seven (47-out of the 61 ears involved) in this study, so far, have achieved complete resolution and no harm/injury was noticed in any of the patients [Tables 1 and 2]. Their ESS [Table 1] also improved significantly from 2.45%–84% to 1%–9.8% (Over 200% to 800%) improvement. Figure 2 is the graphic representation of the ESS, whereas Table 2 depicts the values recorded pre- and post-therapy. Figures 3 and 4 are essential graphic representation of values recorded during the course of the EarPopper Therapy including tympanometry and audiometric tracings. Only about 18.9% had the propensity to progress to chronic OME. This clinical trial highly suggests good prospect in the management of OME among Nigerians. There is a need for an expanded multicenter randomized control study.

Figure 1

EarPoppers and the components

Figure 2

EarPopper scoring system

Figure 3

Tympanometry tracing 1

Figure 4

Tympanometry tracing 2

Recommendations

EarPopper therapy should be considered as first-line treatment option for OME before the contemplation on ear tube insertion to avoid unnecessary surgeries.

CONCLUSION

This clinical trial highly suggests good prospect in the management of OME among Africans. There is a need for an expanded multicenter randomized control study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.