Duration of patency of laser-assisted tympanic membrane fenestration

BACKGROUND: Laser-assisted tympanic membrane fenestration (LTMF) provides intermediate-duration middle ear ventilation, which benefits selected children with acute otitis media (AOM) and otitis media with effusion (OME). OBJECTIVE: To evaluate clinical and technical factors that may affect duration of LTMF patency. DESIGN: Prospective clinical cohort effectiveness trial. SETTING: Four tertiary care children's hospitals. PATIENTS: Volunteer sample of 251 children (430 ears) followed up at 1, 2, 3, 4, 8, and 12 weeks; time to fenestration closure was evaluable in 201 ears, and assessment of cure at study conclusion was evaluable in 128 ears. INTERVENTIONS: Laser-assisted tympanic membrane fenestration for prospectively defined AOM or OME. The surgeon determined spot size, wattage, and concurrent adenoidectomy based on clinical judgment. MAIN OUTCOME MEASURES: Cure of AOM/OME with effusion at 90 days and duration of LTMF patency relative to spot size (1.8-2.8 mm), fenestration location on tympanic membrane, power (7-22 W), concurrent adenoidectomy, age, diagnosis (AOM vs OME), type of effusion, and preoperative tympanogram characteristics. Results are based on the number of ears that could be evaluated at each data collection interval. RESULTS: Fenestrations remained patent for 2 to 4 weeks (mean = 2.52, median = 2.0, SD = 1.4, n = 201); 97.4% were closed at 6-week follow-up. Spot sizes of 2.4 and 2.6 mm had a higher rate of patency than 2.0-mm spot size at 3 weeks following LTMF. Cure at 90 days was related to duration of patency for all patients combined and for patients treated for AOM and OME, but not for those undergoing adjunctive adenoidectomy. Cure at 90 days was related to larger spot size for all patients combined and those treated for AOM. Other investigated factors did not achieve statistical significance. CONCLUSIONS: Spot size of 2.4 mm or greater results in improved duration of LTMF patency, persisting for up to 3 weeks after LTMF, especially for treatment of AOM. Increased duration of LTMF patency correlates with greater incidence of cure of middle ear effusion at 90 days. Additional investigation is indicated to determine optimum spot size and optimum duration of patency for disease- severity-adjusted populations.     

Effectiveness of adenoidectomy and laser tympanic membrane fenestration

Objective Adenoidectomy alone or with tonsillectomy (A±T) is an effective surgical intervention in the management of otitis media in children, especially when it is performed in conjunction with insertion of pressure equalization tubes (PETs). Otorrhea and persistent tympanic membrane (TM) perforation are frequent complications. This study evaluates the effectiveness of intermediate duration middle ear ventilation using laser tympanic membrane fenestration (LTMF) without tube insertion and as an adjunct to adenoidectomy in resolving middle ear disease within the first 90 days after surgery. Study Design This pilot study was a multicenter, prospective clinical cohort trial. Institutional review board approval and informed consent were obtained. The study involved four tertiary care pediatric otolaryngology departments. Fifty children (96 ears) were treated with LTMF in conjunction with A±T from June 1, 1998, through March 30, 1999. Ages ranged from 9 months to 12 years. Patients undergoing A±T who would have been recommended for PET insertion instead underwent middle ear ventilation with LTMF using the OtoLAM? device (ESC/Sharplan, Yokneam, Israel). Patients were seen at 30, 60, and 90 days postoperatively. Resolution of otitis media with effusion was determined by clinical examination, which included pneumatic otoscopy, audiometry, and tympanometry. Results Of the treated ears, 88%, 86%, and 83% had clinical resolution of middle ear disease at 30, 60, and 90 days, respectively. Preoperatively, 45% (n = 85) of ears had normal hearing; 92% (n = 49) had normal hearing at 90 days. Eighty‐nine percent (n = 92) had type C2 or B tympanograms preoperatively, and 12% (n = 60) had type C2 or B at 90 days. Conclusion Laser tympanic membrane fenestration in conjunction with adenoidectomy was effective in restoring normal middle ear function at 90 days post‐treatment in greater than 80% of children who otherwise may have had placement of PETs.     

Office-based laser assisted tympanic membrane fenestration in adults and children: pilot data to support an alternative to traditional approaches to otitis media

OBJECTIVES: To determine the role of intermediate duration ( approximately 3 weeks) middle ear ventilation using office-based laser assisted tympanic membrane fenestration in resolving an episode of otitis media with effusion in adults and children who otherwise would have been treated with insertion of pressure equalization tubes. METHODS: A retrospective chart review of 92 patients (162 ears) was conducted to identify the utility and technical challenges associated with laser assisted tympanic membrane fenestration in an office setting. Clinical characteristics reviewed included: age, gender, duration of effusion, season performed, and hearing and health status of middle ear upon healing of the fenestration. RESULTS: 69% of all patients were effusion free upon closure of the fenestration; 68% of those <3 years; 70% of those 3-7 years; and 70% of those 25-80 years. Some episodes recurred and at final follow-up 64% had normal middle ear structure and function (range of follow-up =1-18 months, mean 2.5 months, median 2.0). Shorter duration of effusion pre-fenestration was more often associated with return to normal middle ear structure and function (P<0.01). Season performed, number of previous episodes of otitis media and pre-treatment tympanometry were not predictive of result. No significant complications were observed. CONCLUSIONS: The use of office-based laser assisted tympanic membrane fenestration is a reasonably safe and effective procedure for the treatment of otitis media in most adults and children. As a minimally invasive otologic procedure, laser assisted tympanic membrane fenestration has great potential to decrease the rates of both antibiotic usage and insertion of ear tubes.     

The feasibility of office-based laser-assisted tympanic membrane fenestration with tympanostomy tube insertion: the duPont Hospital experience.

OBJECTIVE: To determine the feasibility of inserting tympanostomy tubes in children using office-based laser-assisted tympanic membrane fenestration. METHODS AND MATERIALS: Study consisted of a retrospective review of the charts of all children who underwent office-based laser-assisted tympanic membrane fenestration with tympanostomy tube insertion from July 1, 1998 to August 31, 2000. Tetracaine eardrops were used for topical anesthesia. Fenestration was achieved with the OtoLAM flashscanner laser (ESC Sharplan, Yokneam, Israel). RESULTS: Of the 127 patients (185 ears) who underwent laser-assisted tympanic membrane fenestration, 61 ears underwent tympanostomy tube insertion. Ten ears were treated for otitis media with effusion, 43 for recurrent acute otitis media, and eight for acute otitis media not responding to antibiotics. Fifteen ears had purulent effusion, five had a serous effusion, and 23 had mucoid middle ear fluid. Eighteen ears had no middle ear fluid. At the first follow-up visit, all tested ears had hearing of 20 dB or better. Two children had tubes that were blocked. Blockage occurred in ears that required more than one laser firing to penetrate the tympanic membrane. Otorrhea was present in 13 ears (21%). Otorrhea occurred exclusively in ears with purulent or mucoid middle ear fluid. CONCLUSIONS: Office-based laser-assisted tympanic membrane fenestration with tympanostomy tube insertion is a safe and effective alternative to tube placement in the operating room. The outcome compares favorably with previously published data.     

Sensorineural hearing loss in experimental purulent otitis media due to Streptococcus pneumoniae

Sensorineural hearing loss (SNHL) has been described clinically following chronic otitis media with effusion, but to the best of our knowledge, no studies have demonstrated SNHL in an animal model of otitis media. Using the chinchilla model of pneumococcal otitis media, significant SNHL was demonstrated after purulent otitis media, especially at higher frequencies. Animals with otitis media received penicillin G procaine treatment for five days after otitis media with effusion (OME) was first documented; resolution of middle ear infection was confirmed by middle ear effusion culture in all animals. Both the inoculated and uninoculated ears were examined by tone burst-elicited compound action potential at threshold. The inoculated ear showed a marked hearing loss of 13 to 36 dB three to four days after OME was first documented; a hearing loss up to 24 dB persisted two to five weeks after inoculation. The change in the compound action potential was highly significant at all frequencies studied. Conductive losses were largely ruled out because there was no middle ear effusion at death and the tympanogram was normal. Purulent labyrinthitis was ruled out by histopathological study. These results indicate that purulent pneumococcal otitis media in the chinchilla model causes significant SNHL and suggest that the pathogenesis of SNHL associated with chronic OME in humans may be studied in this model.     

Change of middle ear transfer function in otitis media with effusion model of guinea pigs

Otitis media with effusion (OME) is an inflammatory disease of the middle ear that causes most cases of conductive hearing loss observed in the pediatric population. With the long term goal of evaluating middle ear function with OME, the aim of the current study was to create an animal model of OME in which middle ear transfer functions could be measured. In guinea pigs, OME was created by injecting lipopolysaccharide (LPS) into the middle ear. Evidence of OME was assessed by otoscopy, tympanometry, histology, and by measuring the volume of fluid in the middle ear. Vibrations of the umbo and round window membrane were measured with a laser Doppler vibrometer at frequency range of 200-40kHz in three groups of 3, 7, and 14 days after injection of LPS. Changes in displacement of the umbo and round window membrane in response to 80dB SPL sound in the ear canal were measured across the frequency range. Displacement of both the umbo and round window membrane was reduced at all time points following LPS injections. Further, the change of the displacement transmission ratio (DTR) from the tympanic membrane to the round window occurred mainly in chronic (e.g. 14 days post-LPS injection) OME ears. This study provides useful data for analyzing the change of middle ear transfer function in OME ears.     

双耳感音神经性聋患儿合并分泌性中耳炎的临床诊治

目的 探讨双耳感音神经性聋并发分泌性中耳炎患儿的症状特点, 为及时诊治此类患者提供临床依据。方法 收集经手术治疗的双耳感音神经性聋并发分泌性中耳炎患儿(A组)17例(34耳)的病历资料, 分析其误诊原因、临床特点及并发症发生率, 并与同期行手术治疗的单纯双耳单纯分泌性中耳炎患儿(B组)17例(34耳)进行鼓室粘连发生率的比较。手术前后应用听性脑干反应(ABR)检查随诊听力变化。结果 A组均以家属发现听力下降为首诊症状, 在当地首诊曾诊断为突发性聋7例, 耳闷塞感、耳鸣、耳痛等症状叙述不清, 均无法采集到确切的分泌性中耳炎发病时间;行双耳鼓膜置管时发现中耳粘连5例(7耳), 手术前后ABR检查Ⅴ波阈值改善0～30 dB nHL, 平均17.3 dB nHL, 手术前后Ⅴ波阈值改善, 差异有统计学意义(P < 0.05)。B组患儿无1例误诊, 首诊诉耳痛或耳鸣、耳闷塞感等耳部不适症状15例, 发病时间明确, 首诊诉听力下降2例, 鼓膜置管时中耳粘连1例(1耳)。A组并发症发生率高于B组, 差异有统计学意义(P < 0.05)。结论 双耳感音神经性聋并发分泌性中耳炎患儿临床病史采集困难, 易误诊, 临床并发症发生率高, 应及时干预;鼓膜置管对听力改善效果明显。     

Mechanism of hearing loss in irradiated ears: a long-term longitudinal study

A 10-year longitudinal follow-up study of hearing was conducted in patients with nasopharyngeal carcinoma (NPC) in order to elucidate the mechanism of hearing loss in irradiated ears. Ten NPC patients were subjected to a battery of audiological tests before irradiation and 6 months, 5 years, and 10 years after irradiation. The tests included pure tone audiometry, tympanometry, eustachian tube function testing, and myringotomy to confirm middle ear effusion. The prevalences of otitis media with effusion (OME) were 25%, 25%, 40%, and 25% at the 4 testing periods described above, respectively. The prevalences of chronic otitis media were 0%, 0%, 15%, and 25%, respectively. In myringotomized ears (n = 17), the mean hearing levels for both air conduction and bone conduction were preserved from the preirradiation period to 10 years after irradiation. In contrast, in grommeted ears (n = 3), the mean hearing levels for both air conduction and bone conduction deteriorated progressively from the preirradiation period to 10 years after irradiation. We conclude that hearing can be preserved in NPC patients 10 years after irradiation if middle ear inflammation is well controlled. We do not recommend grommet insertion in irradiated NPC patients with OME, as it may result in persistent otorrhea and hearing deterioration.     

Chronic otitis media with effusion sequelae in children treated with tubes

OBJECTIVE: To determine incidence and prevalence of middle ear sequelae and abnormal tympanometry results among children with chronic otitis media with effusion (OME) who received standard treatment with tympanostomy tubes. DESIGN: Prospective cohort study. SETTING: Community clinic and academic medical center.Patients A total of 140 children followed up for 8 years after tube treatment. MAIN OUTCOME MEASURES: Tympanic membrane perforation, atrophy, retraction, hearing loss, myringosclerosis, low static admittance (SA) and broad-peaked tympanogram, high SA and narrow-peaked tympanogram, and negative tympanometric peak pressure. RESULTS: Annual incidence of sequelae was typically greater during 3 to 5 years than 6 to 8 years of follow-up. Greatest increases in incidence during the 5-year follow-up were for atrophy (67%), high SA and narrow-peaked tympanogram (70%), and retraction pocket (47%). Prevalence of these sequelae also increased over time, whereas low SA and broad-peaked tympanogram and negative tympanometric peak pressure decreased during follow-up. Sequela tended to become bilateral over time, and concordance of different sequelae in the same ear was low (kappa, 0.05-0.42). CONCLUSIONS: Annual incidence of sequelae decreased during follow-up. This finding parallels decreasing incidence of OME and tube placement as children mature and demonstrates that sequelae are more likely to develop during active acute and chronic OME. The cumulative effect of incidence resulted in few ears free of sequelae by 8 years of follow-up. Based on this cohort of healthy children with OME, although the risk of sequelae decreased over time, functional and morphologic sequelae were prevalent and may put children at risk for continuing middle ear problems as they grow into adolescence and adulthood.     

Evidence of mast cell activity in the middle ears of children with otitis media with effusion

OBJECTIVES: This is the first study to report the presence of tryptase, a reflection of mast cell activity, in chronic middle ear effusion of patients whose atopic status was characterized. DESIGN AND METHODS: Mediator activity of mast cells and eosinophils was measured prospectively from effusion of 33 randomly selected patients and 5 control subjects with chronic otitis media with effusion (OME). Atopy was determined by enzyme-linked immunosorbent assay. Middle ear biopsies from a second group of 8 OME patients and 4 controls were fixed in plastic and stained immunohistochemically for mast cells. RESULTS: Sixty-one percent of patients had extensive activation of mast cells in their middle ears. Among those with elevated tryptase in their effusion, 95.6% were atopic and 94.7% also had elevated levels of effusion eosinophilic cationic protein (ECP). Tryptase levels were elevated only in the effusion of atopic patients, as compared with 5 controls (P < .01). Mast cells were present in 6 of 8 OME ears and absent in all 4 normal ears. CONCLUSION: Mast cells and its mediator tryptase, both indicators of a Th2-driven immune response, are present in a majority of ears that have chronic effusion. These findings support the hypothesis that middle ear mucosa is capable of an allergic response and that the inflammation within the middle ear of most OME patients is allergic in nature.     

探讨儿童分泌性中耳炎的诊断程序

目的 将鼓室导抗图、纯音听阈与耳CT结果比较,并经鼓膜切开所见验证,分析鼓室导抗图、纯音听阈和耳CT在判断中耳积液的敏感度.方法 分析2007年1月至2008年6月临床诊断分泌性中耳炎住院治疗的患者,将其病史、平均听阈、CT结果进行Logistic分析.结果 40例(75耳)患者中男28例(53耳),女12例(22耳).年龄最小3岁6个月,最大11岁10个月,平均6岁6个月.鼓膜切开证实中耳有分泌物62耳(82.7%),无明显分泌物13耳(17.3%).鼓膜置管23耳.统计学分析结果显示,听力损失程度、CT结果与中耳积液有相关性(r值分别为1.392、1.355;P值均＜0.05).结论 通过鼓膜情况、鼓室导抗图和平均听阈综合判断中耳积液有较高的敏感度.特别以传导性听力损失程度判断有无中耳积液有较高特异性.分泌性中耳炎的患儿,除常规耳科检查,应首先进行声导抗,纯音测听检查.尽管耳CT具有较高的敏感度但是由于其副作用的局限,不建议作为分泌性中耳炎的常规检查.     

Negative middle ear pressure and otitis media with effusion after surgery under general anesthesia

Abstract Conclusion: Negative middle ear pressure was observed in many patients and otitis media with effusion (OME) developed in 3.3% of ears after surgery under general anesthesia. Gas dynamics in the middle ear cavity induced by nitrous oxide inhalation anesthesia and transient blockage of the eustachian tube induced by surgery are considered to be involved in development of OME after surgery under general anesthesia. Objectives: The goal of this prospective study was to investigate middle ear pressure and the prevalence of middle ear effusion in patients after surgery under general anesthesia, to ascertain whether surgery under general anesthesia induces OME. Methods: Otoscopic inspection and tympanometry were performed before surgery (Pre), 1-2 days after surgery (Post-1), and 5-9 days after surgery (Post-2) under general anesthesia in 180 ears of 97 adult patients. Results: Effusion accumulated in the tympanum in six ears (3.3%) of five patients at Post-1. All patients were anesthetized with nitrous oxide. At Post-2, effusion disappeared in all cases. The mean middle ear pressure in all ears was -17.8 daPa at Pre and -60.6 daPa at Post-1, showing a significant reduction from Pre to Post-1 (p < 0.001). At Post-2, the pressure was -18.4 daPa, with no significant difference from that at Pre (p = 0.74).     

Tympanic membrane atrophy, scarring, atelectasis and attic retraction in persistent, untreated otitis media with effusion and following ventilation tube insertion

Two hundred and twenty two children with persistent bilateral otitis media with effusion (OME) were treated with unilateral ventilation tube insertion and no treatment to the contralateral ear. The tympanic membrane changes in the operated and unoperated ears were compared during a 12 year follow-up. Segmental atrophy resulted from tube insertion whereas minor scarring and thickening of the pars tensa was related to the middle ear condition. Eighty three percent of untreated ears and 85% of those treated with tubes did not develop atelectasis. Sixty percent of untreated ears and 64% of treated ears did not develop attic retraction. Very few cases (1.5 and 2%) in untreated and treated ears, respectively developed severe atelectasis. The overall duration of OME was assessed from the pre-operative history of hearing loss, the 3 month period of pre-operative observation and the post-operative time with effusion. There is a relationship between duration of the disease and development of both atelectasis and attic retraction.     

腭裂患儿分泌性中耳炎鼓室置管术疗效分析

目的　观察鼓室置管术在治疗腭裂患儿分泌性中耳炎听力损失的疗效 ,探讨中耳通气管的选择、手术适应证及注意事项。方法　双耳伴发分泌性中耳炎伴听力损失的住院腭裂患儿 19例 ,平均年龄 5 8岁 ,平均气导语频听阈较大的一侧耳在腭裂修复术同期行鼓室置管术 ,对侧未置管耳作为对照组 ,术后 2周至 18个月复查 ,比较置管组及对照组腭裂术前、术后听阈的变化情况。结果置管组耳术后平均气导语频听阈 (2 7 0± 6 5 )dB较术前 (42 7± 8 2 )dB显著降低 ,而对照组耳术前(2 9 0± 6 1)dB、术后 (2 7 0± 4 1)dB听阈差异无显著性。置管组未见严重耳科并发症。结论　腭裂修复术同期鼓室置管术安全、有效 ,可恢复患者听力 ,有利于腭裂术后语音学习。     

感音神经性聋与分泌性中耳炎的相关性研究

目的：探讨感音神经性聋与分泌性中耳炎的关系。方法：对治疗后骨导听力下降仍未恢复的38例分泌性中耳炎患者进行分析，观察健耳和患耳在不同频率的骨导听阈情况，并分别就其发病年龄、病程、积液性质和积液量与骨导听阈的关系进行观察。结果：患耳在不同频率的骨导听阈均大于健耳（均P＜0．01）；年龄愈大、病程愈长，感音神经性聋发生率愈高；积液为黏液者发生率高于浆液者；但与积液量无明显关系。结论：分泌性中耳炎可导致感音神经性聋，其发病原因和机制是多方面的，年龄大、病程长、积液为黏液者更易导致感音神经性聋的发生；应提高认识，早诊断，早治疗。     

Multifrequency tympanometry in adults with otitis media with effusion

We compared the diagnostic values of multifrequency tympanometry (MFT) and conventional 226-Hz tympanometry in adults with otitis media with effusion (OME) and discuss whether the resonant frequency (RF) can be used as a reliable method in adults with OME. Prospective study was designed to compare the normal hearing group and the group with OME. In the OME group (n = 85), conductive or mixed hearing loss was found, air-bone gap was more than 10 dBHL, and acoustic reflex was not elicited. In the normal hearing group (n = 36), pure tone threshold was less than or equal to 15 dBHL and air-bone gap was less than 10 dBHL. Levene's test was used to compare the difference between the OME group and the normal hearing group on day1, day15, day30, day90, respectively. The relationship among multifrequency tympanometry, 226-Hz tympanometry and acoustic reflex test in ears recovering from OME was also investigated. A statistically significant decrease in RF value was found in ears with OME compared to normative data. In follow-up visits, both the RF values and the percentage of type A tympanograms increased while the percentage of type B and C tympanograms decreased. A high agreement between middle ear resonant frequency test and acoustic reflex test in ears recovering from OME was found. The resonant frequency test provides more detailed information than the 226-Hz tympanometry. Multifrequency tympanometry may be a more sensitive and objective diagnostic tool in adults with OME.     

Does Helicobacter pylori have role in development of otitis media with effusion?

OBJECTIVE: Recently, it was suggested that tonsil and adenoid tissues may act as a reservoir for Helicobacter pylori (HP). A connection between chronic tubotympanal disorders and gastroesophageal reflux is well recognized, but the mechanism underlying this relationship is unclear. In this study, we investigated possible presence of HP in adenoid tissue and middle ear effusions in patients with chronic otitis media with effusion (OME) and we compared the data with the results of the children who had adenoid hypertrophy without OME. METHODS: The study was comprised of 38 consecutive children with adenoid hypertrophy and/or chronic OME. The patients were divided into two groups. The first group included 18 subjects having OME+adenoid hypertrophy and the second group included 20 subjects having solely adenoid hypertrophy. Each patient underwent the appropriate surgical procedure; myringotomy, placement of tympanostomy tubes and/or adenoidectomy. After myringotomy, the middle ear effusions were collected in a suction and collection device and a core biopsy specimen was taken from each adenoid tissue following adenoidectomy. DNA extracted from these samples was used for the amplification of 23S ribosomal RNA gene of HP by real-time polymerase chain reaction (RT-PCR). RESULTS: In the first group 34 effusion samples were obtained from ears of 18 patients (two had unilateral OME). HP was found to be positive in 12 children (67%) and 16 of 34 ears (47%) with RT-PCR. In eight children HP was positive in only one ear and in four children in both ears. No positive reaction was seen in tissue samples obtained from adenoids of these patients. In the second group a positive reaction was seen in adenoid tissue of only one patient. CONCLUSIONS: This study showed that there is HP presence in middle ears of the children with chronic OME, indicating HP having a possible role in OME pathogenesis. In addition, we demonstrated HP presence in only 1 of 38 adenoid specimens supporting the idea that adenoid tissue does not act as a reservoir for HP.     

Gas exchange function of the middle ear in patients with otitis media with effusion

Gas exchange function through the middle ear mucosa was assessed using nitrous oxide (N₂O) in patients with otitis media with effusion (OME), as well as in normal ears during elective surgery for unrelated disorders. In all normal ears except one (n = 43), an increase in pressure was observed after N₂O inhalation. In 42 of 84 ears with OME, a pressure increase was observed, but not in the remaining 42 ears (50%), indicating that the gas exchange function in these latter ears was impaired. In 21 of the 42 ears showing no middle ear pressure increase following N₂O inhalation, the middle ear pressure was again monitored after myringotomy and aspiration of the effusion A pressure increase was found in 16 ears, indicating that the impairment in gas exchange function in ears with OME may be reversible in most cases. Computed tomography of the mastoid was examined preoperatively in 66 ears, with the presence or absence of a middle ear pressure change well correlated in 57 ears with the presence or absence of mastoid aeration.     

Detection of Helicobacter pylori in children with otitis media with effusion: a preliminary report

OBJECTIVE: To determine the presence of Helicobacter pylori in the middle ear effusion of patients with otitis media with effusion (OME) by polymerase chain reaction (PCR). STUDY DESIGN: A prospective study in patients with OME. METHODS: The study was performed in 38 patients with OME who were admitted to the ENT Clinic, Firat University from June 2003 to April 2004. In all cases, a myringotomy operation (with or without placement of a ventilation tube) was carried out. The effusion samples aspirated from the middle ear were analyzed with PCR assay. RESULTS: A total of 55 aspiration samples collected from 38 children ranging in age from 2 to 12 were included in the study. Fifteen of the subjects were girls, and 23 were boys. In 17 patients, both ears demonstrated effusions, whereas in 21 patients, only one ear had effusions. Nine (16.3%) of 55 the middle ear effusion samples were shown to be H. pylori positive by PCR. CONCLUSIONS: H. pylori was detected in the middle ear effusion of some patients with OME. These results may have interesting implications for a possible role of H. pylori in OME. In addition, these results suggest that further studies are needed to investigate the role of H. pylori in the etiology of OME.