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Multicenter, randomized, double-blind comparison of erythromycin estolate versus amoxicillin for the treatment of acute otitis media in children. AOM Study Group.

Erythromycin is frequently prescribed in Germany for acute otitis media, but well-designed clinical trials under present epidemiological conditions are lacking. Therefore, a double-blind, randomized, multicenter trial was performed to compare the clinical efficacy and safety of erythromycin estolate versus amoxicillin in children with acute otitis media and to identify the risk factors associated with clinical failure. Investigators from 19 centers throughout Germany recruited 302 children with clinical, otoscopic, and tympanometric evidence of acute otitis media. In a double-blind fashion, patients were allocated randomly to a 10-day course of erythromycin estolate at 40 mg/kg/day in two divided doses or amoxicillin at 50 mg/kg/day in two divided doses. Clinical examinations, otoscopy, and tympanometry were performed at baseline, day 3-5, day 9-11, and at 5 weeks. Clinical outcome was assessed on day 9-11. Two-hundred eighty children were evaluable for efficacy (erythromycin group, 141; amoxicillin group, 139). Both groups were comparable with respect to demographic data and severity of disease at entry. Treatment was successful in 94% of the erythromycin-treated patients and in 96% of the amoxicillin-treated patients. Clinical outcome was statistically equivalent between groups within a range of 7 percentage points. Clinical recurrence was seen in eight erythromycin-treated children (5.7%) and in seven amoxicillin-treated children (5.0%) (P=0.81). Patients with bilateral disease at entry were at higher risk of unfavourable outcome, whereas age and presence/absence of otorrhea at entry were not associated with outcome. Treatment-related adverse events were recorded in eight (5.3%) of 151 erythromycin-treated patients and in 11 (7.3%) of 151 amoxicillin-treated patients. In this study in an outpatient setting in Germany, erythromycin estolate was as safe and effective as amoxicillin in the treatment of acute otitis media. Both drugs can be administered in a convenient twice-daily dosage schedule.

Acute Disease↗

Multi-investigator evaluation of the efficacy and safety of cefprozil, amoxicillin-clavulanate, cefixime and cefaclor in the treatment of acute otitis media.

Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Acute Disease↗

Long-term otologic status of older cleft palate patients.

The purpose of this study was to evaluate the effectiveness of regular otologic care on the long-term outcome in patients with cleft palates. We report the otoscopic and audiologic findings of 50 patients who were followed regularly at our center for an average of 15.4 years. All these patients had their cleft palates repaired by the same surgical team and all ears were examined by one of the authors under the microscope and a chart review completed. Thirty eight patients had at least one tube placement. The physical abnormalities noted were tympanosclerosis (36%), retraction of tympanic membrane (TM) (20%), atrophy of TM (15%), perforation (11%), PE tube in situ (11%), thick TM (6%) and PE tube in middle ear (1%). The examination was normal in 36%. A conductive loss was noted in 18% and sensorineural loss in 3%. The results of this study support the concept of regular otologic care for cleft palate patients even when they are overtly asymptomatic.

Adolescent↗

Laser myringotomy in otitis media with effusion: long-term follow-up.

Otitis media with effusion is a leading cause of conductive hearing loss in children. Myringotomy and insertion of tympanostomy tubes is the accepted form of treatment. Recently, several studies utilizing laser myringotomy have been published, but few of them present late results. The objective of this study was to compare late results of the treatment with laser and classical myringotomy. A clinical effectiveness trial was conducted in three groups of children: (1) 37 children treated with laser myringotomy (ML), (2) 29 children treated with laser myringotomy and the insertion of tympanostomy tubes (ML+V) and (3) 43 children treated with classical myringotomy and the insertion of tympanostomy tubes (MC+V). All types of surgery were performed under general anesthesia because adenoidectomy and/or tonsillectomy was done at the same time. The results of treatment were assessed on the basis of the otoscopic examination (recurrences of effusion, condition of the tympanic membrane, and audiological examination (pure-tone audiometry, tympanometry and DPOAE). The minimum follow-up period was 1 year. The recurrence rate was lowest in the ML+V (11%) group, and highest in the ML group (36%). The difference between ML+V and MC+V was not significant. Permanent changes in the tympanic membrane were observed in 8% of the ears after ML, 19% after ML+V and 31% after MC+V. The difference was significant between the ML and MC+V groups. PTA was significantly higher in the MC+V group than in the control group of otologically healthy children. Mean amplitudes of DPOAE, measured in treated children with normal tympanometry results, were significantly lower than in the control group, but within the normal range. The use of CO(2) laser during myringotomy has no negative effect on the function of the cochlea. Healing of the tympanic membrane after laser myringotomy was uneventful with a low percentage of permanent sequelae.

Audiometry↗

Otoacoustic emissions in an aberrant internal carotid artery: a case report.

A 52-year-old Korean woman who complained of impaired hearing and tinnitus of the left ear was diagnosed with an aberrant internal carotid artery (ICA) in the middle ear using a temporal bone high resolution CT (HRCT) scan. Upon otoscopic examination, her left eardrum was found to be in contact with a mass in the middle ear cavity. Upon audiometric evaluation, a mild conductive hearing impairment was documented, and a discrepancy in the results of otoacoustic emissions (OAEs) was found for the left ear. This case report studies the aberrant ICA in the middle ear that revealed abnormal OAE findings.

Audiometry↗

Effect of the status after ear surgery and ear pathology on the results of infrared tympanic thermometry.

Most publications that deal with infrared tympanic thermometry (ITT) have performed a comparison between the established temperature measurements and ITT. However, to date an understanding of the influence of pathological ear findings on ITT test results is incomplete. Therefore, in the present study ITT was performed in healthy adults (n =21), adult patients with monaural central perforation (n =31) or strong scar formations (n =24) of the tympanic membrane and 18 adult patients after monaural canal wall down surgery. Right and left ear and oral temperature were measured three times by one investigator in a room with a constant temperature of 20-22 degrees C. Between every measurement there was a free time interval of 2 min. In healthy adults (36.50 degrees C vs. 36.51 degrees C) patients with monaural central perforation of the tympanic membrane (36.41 degrees C vs. 36.34 degrees C) and with monaural strong scar formations in the tympanic membrane (36.39 degrees C vs. 36.45 degrees C), no significant difference between the right and left ear could be proved. In contrast to this, a significantly higher temperature in the surgically treated ear compared to the healthy side (36.97 degrees C vs. 36.31 degrees C; P <0.001) occurred in patients with a status of after monaural canal wall down surgery. In summary, it could be demonstrated that, in contrast to minor ear surgery, major ear surgery such as canal wall down has a significant influence on the results of ITT. If a patient's history gives reference to previous ear surgery, an otoscopic examination is necessary in order to exclude the presence of an after-canal-wall-down surgery status and thus to avoid false ITT test results.

Adult↗

Primary papillary adenocarcinoma confined to the middle ear and mastoid.

Primary adenocarcinoma is a rare tumor of the middle ear and temporal bone; its most frequent symptoms are hearing loss, otalgia, and facial paralysis. Otoscopic examination of a 27-year-old man revealed purulent discharge in the ear canal, diffuse edema, and hypertrophy of the right tympanic membrane. He presented with a grade III (House-Brachman) facial paralysis and right conductive hearing loss with a history of aural discharge for 6 months, otalgia, and facial weakness for 2 days. Computed tomography of the temporal bone showed an opacity filling the tympanic cavity, antrum, and aditus. Tympanotomy revealed diffuse edema of the middle ear mucosa, and granulation tissue was encountered during mastoidectomy filling the antrum and periantral cells and eroding the fallopian canal at the level of the oval window. After the histopathological examination revealed papillary adenocarcinoma, a subtotal temporal bone resection, facial nerve segmenter resection, and end-to-end anastomosis of the facial with the hypoglossal nerves were performed. The importance of histopathological examination in all cases of chronic otitis media with granulation tissue is stressed.

Adenocarcinoma, Papillary↗

Steroids, carbogen or placebo for sudden hearing loss: a prospective double-blind study.

There is no consensus regarding treatment modalities for idiopathic sudden sensorineural hearing loss (SNHL). In order to evaluate the effectiveness of steroid or carbogen inhalation therapies, a prospective double-blind placebo controlled study was designed. All 41 patients enrolled in the study had unilateral SNHL with no prior history of SNHL, otological pathological history or otoscopic findings. Patients were assigned to four treatment groups: prednisone tablets, placebo tablets, carbogen inhalation or room air inhalation. All were treated for 5 days. The audiometric data at admission was compared to that at day 6 and to data collected at follow-up (average 33 days). Results revealed no significant difference between the groups for early or late audiometric outcome. Age, time from onset of symptoms to initiation of treatment, tinnitus, audiogram configuration, and the presence of vertigo at onset did not significantly affect the outcome. The discrimination scores that were poor in all patient groups on admission improved within days in all groups. These findings suggest that steroids or carbogen inhalation have no therapeutic advantage over placebo. Also, regardless of treatment modality, hearing continued to improve for at least a month after treatment was stopped.

Acute Disease↗

Hearing loss among operating engineers in American construction industry.

OBJECTIVE: Occupational noise exposure and noise-induced hearing loss (NIHL) among construction workers has long been recognized as a problem in the United States, yet little is known about the prevalence of NIHL among American construction workers. The purpose of this study was to determine the prevalence and characteristics of hearing loss among operating engineers (OEs) who operate heavy construction machinery. METHOD: As a part of hearing protection intervention, an audiometric test was conducted for both ears at frequencies 0.5 through 8 kHz in the soundproof booth. Prior to the audiometric test, a paper-pencil pre-hearing test questionnaire was administered and an otoscopic examination was completed. Prevalence of hearing loss was determined based on hearing threshold levels (HTLs) in the worst ear with a low fence of 25 dB. RESULT: A total of 623 workers were included in the analysis and they were predominantly middle-aged Caucasian males (mean age = 43 years, Caucasian = 90%, male = 92%). Over 60% of OEs showed hearing loss in the noise-sensitive higher frequencies of 4 and 6 kHz. The rate of hearing loss was particularly higher among workers who reported longer years of working in the construction industry. Workers showed significantly poorer hearing in the left ear, and a typical characteristic of NIHL, a V-notch at 4 or 6 kHz, was not shown in this population. Thirty-eight percent reported ringing/buzzing in the ear and 62% indicated having problems in understanding what people say in loud noise. Average reported use of hearing protection devices (HPDs) was 48% of the time they were required to be used. Significant inverse relationship was found between higher frequency (4-6 kHz) hearing loss and use of HPDs (r =-0.134, p < 0.001). Workers using HPDs more had significantly better hearing than those who did not. CONCLUSION: The study demonstrated a significant NIHL problem and low use of HPDs in OEs. An effective hearing conservation program, including a periodic audiometric testing and hearing protection intervention, for this study population should be in place.

Adult↗

Parental suspicion of hearing loss in children with otitis media with effusion.

OBJECTIVE: This study aimed to evaluate the parental suspicion of hearing loss in children with otitis media with effusion (OME). As part of a population-based survey in a screening programme among 6- to 7-year-old Chinese children in Hong Kong, OME cases and controls were studied for the value of parental observations in the prediction of OME and hearing test results. SUBJECTS AND METHODS: Prior to the otoscopic and tympanometric examination of the children on school premises, a self-administered binary-choice question was sent to the parents asking whether there was any suspicion of hearing impairment. Positive screens and randomly selected negative screens were seen in a hospital clinic for the confirmation of case and control status 2 to 3 weeks after the school screening. Aural examination under microscopy, repeated tympanometry and stapedial reflex testing, and pure-tone audiometry (PTA) were conducted, and 117 cases and 159 controls were included in this study. RESULTS: The average PTA conductive threshold levels in the individual children with OME ranged from 3.8 dB to 40.0 dB with a group mean of 17.0 dB in the better-hearing ears. Parental suspicion of hearing deficit was significantly associated with OME (p<0.001) but not PTA findings (p=0.686). The sensitivity of parent-suspected hearing impairment to detect OME however was very low (19.7%). DISCUSSION: In other words, if we had relied on parental suspicion as the first screening, at least 80% of the OME cases would have been missed. We conclude that the parental suspicion of hearing loss is inadequate for the identification of mild hearing loss as caused by OME. Health education is recommended to improve parental awareness of the disease.

Auditory Threshold↗

Combined intra-operative monitoring of hearing by means of auditory brainstem responses (ABR) and transtympanic electrocochleography (ECochG) during surgery of intra- and extrameatal acoustic neurinomas.

BACKGROUND: Although being established as a standard procedure in intra-operative monitoring in acoustic neurinoma surgery, auditory brainstem responses (ABR) represent a far-field technique bearing some technical limitations. This prospective study was designed to evaluate electrocochleography (ECochG) as a supplementary tool for hearing preservation. METHOD: 84 patients with unilateral intra-/extrameatal acoustic neurinomas (extrameatal diameter: 5-55 mm) preserving serviceable hearing, were operated on using a combined (neuro-/otosurgical) suboccipital approach. ECochG was recorded simultaneously to ABR following transtympanic insertion of a steel needle electrode into the promontory under otoscopic view. FINDINGS: Serviceable hearing (Class 1-3 according to Gardner/Robertson) was preserved in 43 out of 84 patients (51.2%), of whom 40 showed both ECochG and ABR being preserved. All 24 patients with loss of both modalities became deaf. Hearing preservation was observed in 4 out of 12 patients with preserved ECochG but loss of ABR (waves III-V). The reverse was observed in 2 cases with postoperative deafness. While both ECochG and ABR amplitudes were significantly correlated with pre- and postoperative hearing, latencies of ECochG summating (SP) and action potential (AP) proved to be more reliable indicators for preserved hearing than ABR (peak I/III/V) latencies. The predictive value of baseline ABR amplitudes for postoperative hearing, however, was superior to ECochG parameters. Only in large neurinomas (extrameatal diameter: >2 cm) tumour size was found to be a significant predictor for the preservation of hearing. Apart from three cases with postoperative otoliquorrhea and one further case presenting with local bleeding within the external acoustic meatus, no side effects were observed. CONCLUSIONS: In combination with ABR monitoring, ECochG proved to be a useful supplementary tool for hearing preservation in acoustic neurinoma surgery. It is particularly helpful during electrocautery and drilling, since no averaging is required. Special applications are: (1) small tumours with good serviceable hearing; (2) and/or a large intrameatal portion; (3) cases with lost or endangered contralateral hearing (e.g. bilateral acoustic neurinomas), when the preservation of poor or even non-functional hearing is desirable.

Adult↗

Diagnostic accuracy of otitis media and tympanocentesis skills assessment among pediatricians.

The comparative study presented here evaluated pediatricians from Italy, Greece, South Africa, and a reference group in the USA to determine (i) their ability to accurately diagnose acute otitis media (AOM) and otitis media with effusion (OME) using otoscopy, (ii) their knowledge of antibiotics, and (iii) their technical competence in performing tympanocentesis. The participants included 66 pediatricians from Italy, 115 from Greece, 36 from South Africa and 2,190 from the USA (reference group). Each pediatrician viewed nine video-recorded otoscopic examinations of tympanic membranes, after which their ability to differentiate AOM, OME and normal was ascertained. Questions were posed regarding appropriate, pathogen-directed antibiotic selection for AOM. A mannequin model was used to assess the technical proficiency of each pediatrician in performing tympanocentesis. Results were recorded for each group as the mean percentage +/- standard deviation. The correct diagnosis was made by each group of pediatricians in the following frequencies: Italy, 54+/-27% (range, 18-94%); Greece, 36+/-12% (range, 23-56%); South Africa, 53+/-21% (range, 22-88%); and the USA, 51+/-11% (range, 29-72%). The difference between results from Greece and the US reference group was statistically significant ( P=0.002). Pediatricians from each group over-diagnosed AOM with the following frequencies: Italy, 18+/-19% (range, 2-49%); Greece, 34+/-13% (8-50%); South Africa, 23+/-14% (7-44%); and the US reference group, 26+/-19% (7-51%). Pediatricians correctly selected an antibiotic recommended for treatment of AOM caused by drug-resistant Streptococcus pneumoniae as follows: Italy, 89%; Greece, 77%; South Africa, 82%; and the USA, 80%. For treatment of beta-lactamase-producing Haemophilus influenzae, the results were: Italy, 90%; Greece, 70%; South Africa, 81%; and the USA, 77%. Tympanocentesis was optimally performed by >/=86% of all pediatricians. The results indicate that pediatricians may often misdiagnose OME as AOM, but they select appropriate antibiotics about 80% of the time and can be trained to accurately perform tympanocentesis.

Anti-Bacterial Agents↗

Chronic secretory otitis media.

Of 242 children and teenagers treated surgically for chronic secretory otitis media in 1972, 212 presented for evaluation 5 years later. Although the pure-tone audiometric threshold was 20 dB HL or better in 87.7% of the ears, only 40.6% were judged to be otoscopically normal. The findings at the first myringotomy for insertion of tympanostomy tubes were of no prognostic value for the course of the disease, and the presence of characteristics of middle ear fluid at subsequent myringotomies varied unpredictably. Adenoidectomy performed at an early stage, and in the presence of nasal obstruction, resulted in a significant reduction in the need for re-insertion of tympanostomy tubes.

Acoustic Impedance Tests↗

Tympanometric findings in young infants with middle ear effusion: some further observations.

This study sought to investigate further the role of tympanometry in detecting otitis media with effusion (OME) in infants 5 months of age and below. Tympanometric data were obtained from 26 infants (40 ears) with pneumo-otoscopic diagnosis of OME. Results demonstrated normal tympanograms for 8 (20%) of the 40 ears despite the presence of effusion. Results are discussed relative to the possible explanation for normal tympanograms with fluid present in young infants.

Acoustic Impedance Tests↗

Screening for middle-ear disease in schools for hearing-impaired children.

The aim of the study was to determine the prevalence of middle-ear dysfunction in a group of hearing-impaired children attending schools for the deaf. Two groups of subjects between the ages of 4 and 16 years were selected. Group 1 consists of Caucasian and Group 2 of Negroid children. Otoscopic examinations, impedance and pure tone testing were performed on each child. The results indicated a prevalence of 43% failures on the impedance tests in the Caucasian group and 18% failures in the Negroid group. Chronic problems like perforations, otorrhoea, etc. were more common in Group 2. The results also suggest the existence of differences in the prevalence of middle-ear dysfunction between normal and hearing-impaired children.

Acoustic Impedance Tests↗

Epidemiology of chronic suppurative otitis media in Saudi children.

An epidemiological survey was carried out in Riyadh to establish the prevalence of chronic suppurative otitis media in Saudi children. 6421 children aged 2 months to 12 years were examined clinically, their ears were inspected by otoscopic examination by an ENT specialist, and the evaluation of hearing was undertaken by an audiologist using a memory screening audiometer (Madson 84-11). Ninety-four children (1.5%) had chronic ear disease being of the following types: congenital cholesteatoma (n = 1), acquired cholesteatoma and posterosuperior retraction (n = 5), and central perforation (n = 88), 16 of which had active ear discharge. These results were compared with other results in developed and developing countries. The factors predisposing to or associated with chronic ear disease such as environmental, genetic, congenital ear anomalies and cleft palate have been discussed.

Child↗

Ossicular abnormality in Larsen's syndrome: a case report.

Larsen's syndrome consists of a skeletal dysplasia with multiple joint abnormalities and a characteristic facies. No reports of this syndrome have documented hearing loss due to ossicular joint abnormalities. A 6-year-old girl is presented with the characteristic abnormalities of Larsen's syndrome, a normal otoscopic examination, and significant bilateral conductive hearing loss. Exploratory tympanotomy demonstrated an incudostapedial joint abnormality, as well as a fixed stapes footplate. The possibility of ossicular joint abnormalities, in addition to the other joint abnormalities associated with this syndrome, must be considered.

Child↗

Developmental defects of the tympanic plate: case reports and review of the literature.

A complete otoscopic examination should be performed in all patients seeking treatment of temporomandibular disorders. The presence of a bulge in the external auditory meatus that disappears with mouth opening may suggest the persistence of the foramen of Huschke. The clinician should rule out the presence or history of infection, trauma, or neoplasm before ascribing the etiology of a defect to a developmental aberration.

Aged↗