Phase I Study in Healthy Women of a Novel Antimycotic Vaginal Ovule Combining Econazole and Benzydamine.

Purpose: A novel fixed-dose combination of 150 mg of econazole with 6 mg of benzydamine formulated in vaginal ovules was investigated in a randomised, double-blind, four-parallel group, tolerability, and pharmacokinetic Phase I study in healthy women. Methods: The fixed-dose combination was compared to econazole and benzydamine single-drug formulations and with placebo after daily applications for 3 consecutive days. Safety and tolerability were evaluated recording the adverse drug reactions, local and general tolerability scores, clinical laboratory assays, and vital signs. Econazole, benzydamine, and its metabolite benzydamine N-oxide pharmacokinetics were investigated after single and multiple applications. Results: Local reactions were generally absent. Pruritus and pain at the application site were infrequently reported. According to the subjects' evaluations, the overall tolerability of the ovules was rated as excellent or good. No significant effect of any treatment on laboratory parameters, vital signs, body weight, vaginal pH, or ECG was observed. Very low econazole, benzydamine, and benzydamine-N-oxide concentrations were measured in plasma, though quantifiable in almost all samples. Conclusion: The tested fixed-dose combination showed a good safety profile consistently with the known tolerability of both active substances. In addition, the confirmed low bioavailability of the drugs excludes the possibility of any accumulation effects and limits the risk of undesired systemic effects. This trial is registered at ClinicalTrials.gov with the identifier NCT02720783 last updated on 07 February 2017.

Hearing threshold estimation by auditory steady state responses (ASSR) in children.

Hearing threshold identification in very young children is always problematic and challenging. Electrophysiological testing such as auditory brainstem responses (ABR) is still considered the most reliable technique for defining the hearing threshold. However, over recent years there has been increasing evidence to support the role of auditory steady-state response (ASSR). Retrospective study. Forty-two children, age range 3-189 months, were evaluated for a total of 83 ears. All patients were affected by sensorineural hearing loss (thresholds ≥ 40 dB HL according to a click-ABR assessment). All patients underwent ABRs, ASSR and pure tone audiometry (PTA), with the latter performed according to the child's mental and physical development. Subjects were divided into two groups: A and B. The latter performed all hearing investigations at the same time as they were older than subjects in group A, and it was then possible to achieve electrophysiological and PTA tests in close temporal sequence. There was no significant difference between the threshold levels identified at the frequencies tested (0.25, 0.5, 1, 2 and 4 kHz), by PTA, ABR and ASSR between the two groups (Mann Whitney U test, p < 0.05). Moreover, for group A, there was no significant difference between the ASSR and ABR thresholds when the children were very young and the PTA thresholds subsequently identified at a later stage. Our results show that ASSR can be considered an effective procedure and a reliable test, particularly when predicting hearing threshold in very young children at lower frequencies (including 0.5 kHz).

Idiopathic sudden sensorineural hearing loss: cardiovascular risk factors do not influence hearing threshold recovery.

Previous studies have suggested that risk factors for ischaemic vascular disease, such as cigarette smoking, hypertension and hyperlipidaemia, can also be considered risk factors for the development of idiopathic sudden sensorineural hearing loss (ISSNHL). In this study, we have evaluated the hypothesis that these factors can influence hearing threshold recovery in patients affected by ISSNHL. A total of 141 subjects who suffered an episode of ISSNHL were included. All subjects were assessed with tonal audiometry, auditory brainstem responses and MRI to exclude retrocochlear pathology. Hearing tests were conducted at ISSNHL onset (t = 0) and after 30 days. Patients were divided into three classes according to the presence/absence of one or more cardiovascular risk factors including: history of smoking, total serum cholesterol/triglycerides, history of hypertension and diabetes mellitus. Values of hearing threshold recovery were estimated and comparisons were conducted across the three risk factor classes. 75% of patients affected by ISSNHL showed a threshold recovery. However, the threshold recovery was found to be class-independent (average recovery value of 18 dB HL per classes) and also independent of age and gender. Even if cardiovascular risk factors have been found to be involved in the pathogenesis of ISSNHL, the present study suggests that these factors do not have any significant influence on the threshold recovery in ISSNHL.

Mastoiditis in adults: a 19-year retrospective study.

The objective of our study was to review retrospectively the clinical, radiological and therapeutic findings in 62 adults with acute mastoiditis treated at the ENT Department of Ferrara from 1992 to 2010. 62 adult cases fulfilled the following inclusion criteria: otoscopical evidence of co-existent or recent otitis media; postauricular swelling, erythema or tenderness; protrusion of the auricle; fever and/or significant radiological findings of mastoiditis. Conservative treatment comprehended antibiotic ± ventilation tube. Surgical procedures comprehended mastoidectomy or mastoido-tympanoplasty. The incidence of adult's mastoiditis in our district (0.99 cases/year/100.000 inhabitants) has maintained quite stable during the considered 19-year period. The typical clinical presentation was observed in 48% of cases. Complications were meningitis (15 cases), meningo-encephalitis (1), meningitis associated with lateral sinus thrombosis (1), facial nerve paralysis (11), and labyrinthitis (8). In all cases except one, the facial palsy recovered completely and no mortality was observed due to these complications. Complete cure was obtained with conservative treatment in 69% of uncomplicated cases and in 24% of patients with intracranial complications. Mastoiditis in adults may present as the acute classical form, as well as latent forms which often have prolonged and insidious development followed by a rapid clinical deterioration. Clinical features are frequently atypical, while incidence of meningitis and other complications is still high particularly in the most elderly. Thus, great care is required from clinicians to make an early diagnosis in order to promote adequate treatment.

Prulifloxacin versus levofloxacin in the treatment of severe COPD patients with acute exacerbations of chronic bronchitis.

RATIONALE: Antimicrobial therapy of chronic bronchitis exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) is based on empiric antibiotic treatment. OBJECTIVES: To evaluate the efficacy of prulifloxacin versus levofloxacin therapy in severe COPD patients with exacerbations of chronic bronchitis. METHODS: This study involved a multicenter, parallel, double-blind, randomized clinical trial. Patients aged 40 years or older, smokers, or ex-smokers (>10 pack-years) with spirometrically confirmed severe COPD (FEV1 ≤ 50% predicted and FEV1/FVC ratio < 0.7) and diagnosed with an acute exacerbation of chronic bronchitis were enrolled in the study. Patients were randomized to receive prulifloxacin 600 mg once a day or levofloxacin 500 mg once a day for 7 days. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was clinical assessment at the TOC visit (7-10 days after the end of treatment) of signs and symptoms of exacerbation, namely sputum purulence, sputum volume, dyspnoea, cough and body temperature assessed through semi-quantitative scales. The ITT population included 346 (174 prulifloxacin, 172 levofloxacin) out of 351 treated subjects. A total of 161 patients with prulifloxacin (92.5%) and 166 with levofloxacin (96.5%) were considered cured at TOC (the difference in the percentage of cured patients was -3.98 with 95%CI of -8.76; 0.79). At the 6-month follow-up, the rates of patients with no relapse of AECB were higher than 95% in both the prulifloxacin and levofloxacin groups. CONCLUSIONS: Both prulifloxacin and levofloxacin showed efficacy rates higher than 90% in the treatment of severe COPD patients with exacerbations of chronic bronchitis, with no statistically significant differences between the two antibiotics. The long-term follow-up confirmed a very low incidence of relapse, endorsing the appropriateness of this therapeutic approach. EUDRACT no. 2006-004167-56.

Postoperative complications in cochlear implants: a retrospective analysis of 438 consecutive cases.

Our objective is to determine the complication rate in a population of infants, children, adolescents and adults, from a University Hospital Cochlear Implant program and to discuss their causes and treatments. The methods include a retrospective study of 438 consecutive patients in a tertiary referral centre, the Audiology Department of the University Hospital of Ferrara. All patients receiving cochlear implants, between 1 January 2003 and 31 December 2009, have been included. All complications and treatments were systematically reviewed with an average duration of follow-up of 46 months (range 10-84 months). The results reveal that the overall rate of complications in our group was 9.1% (40 of 438), and most of them were minor. Wound swelling and infections represent the most common complication occurred. There were no cases of transient or permanent facial palsy following surgery, and also we did not register any case of postsurgical meningitis. Thirteen patients (3.0%) underwent explantation followed by reimplantation. In conclusion, we find that Cochlear implantation is a safe low-morbility technique with a relatively low complication rate in the presented population.

Are systemic oral steroids effective for sensorineural hearing loss in bullous myringitis? Considerations from a preliminary study.

BACKGROUND: It is common in clinical practice to administer systemic steroids to treat sensorineural hearing loss due to bullous myringitis (BM). Nonetheless, there is currently no definitive evidence that steroid therapy is effective and appropriate for BM. OBJECTIVE: The aim of this study was to assess the effectiveness of systemic steroid therapy for treating BM. PATIENTS AND METHODS: This prospective study included 23 patients affected by BM with sensorineural hearing loss (median age, 45.8 years). The subjects were divided into two groups: Group A received only systemic antibiotic treatment and Group B received systemic antibiotics plus systemic steroid treatment. RESULTS AND CONCLUSIONS: There were no differences between the groups in terms of the sensorineural hearing loss recovery. Both treatments were effective, suggesting that administration of oral steroids in combination with antibiotics did not confer an advantage in terms of sensorineural hearing loss recovery rate in the tested population.

Acute mastoiditis in children: the "Ferrara" experience.

OBJECTIVE: This study aims to investigate the clinical features and outcomes of acute mastoiditis in children referred to the ENT/Audiology Department of the University of Ferrara from January 1994 to December 2005. It also aims to discuss risk factors and to find predictors for surgery. METHODS: A retrospective study on case sheets of children with an acute mastoiditis diagnosis was carried out. Fifty-five cases fulfilled the inclusion criteria: they presented otoscopical evidence of acute otitis media and inflammatory findings of the mastoid area such as post-auricular swelling, redness or tenderness, protrusion of the auricle and/or radiological findings. RESULTS: Twenty-six patients were only treated with antibiotic therapy, tympanocentesis alone was performed in 11 cases; in 5, a ventilation tube was positioned. Mastoidectomy was performed in 13 patients. The group who underwent mastoidectomy had a median hospital stay of 15 days (5-54), in this group were found the following complications: 1 meningitis, 1 meningo-encephalitis, 1 lateral and sigmoid sinus thrombosis, 1 facial palsy. CONCLUSION: the incidence of otomastoiditis does not seem to be decreasing, on the contrary, in some countries, it seems to be on the increase. Our experience cannot confirm a real increase of the incidence but we noted periodic variations during the time of observation. It is important, that careful attention is paid to the clinical assessment of children who are 2-years old or under, as they seem to be more exposed to the risk of clinical complications; therefore, it is highly recommended that the otologist and the paediatrician collaborate closely.

Prulifloxacin versus ciprofloxacin in the treatment of adults with complicated urinary tract infections.

INTRODUCTION: The present study was performed to evaluate the efficacy and safety of a 10-day regimen of prulifloxacin 600 mg once daily as compared to ciprofloxacin 500 mg twice daily in the treatment of patients with complicated urinary tract infections (UTIs). MATERIALS AND METHODS: 257 patients (mean age +/- SD 62.3 +/- 16.5) were enrolled and orally treated with prulifloxacin (127 patients) or ciprofloxacin (130 patients). The study was designed as a randomized, double-blind, double-dummy, controlled clinical trial. The primary efficacy parameter was the eradication of infecting strains (<10(3) cfu/ml). The clinical outcome and tolerability were also assessed. RESULTS: At baseline, the most common infecting strains were Escherichia coli (62.8%), Proteus mirabilis (7.1%) and Klebsiella pneumoniae (4.1%). At the early follow-up, the rate of patients showing successful treatment was 90.8% in the prulifloxacin group, and 77.8% in the ciprofloxacin group (p = 0.008). A positive clinical outcome was observed in 94.8 and 93.3% of prulifloxacin- and ciprofloxacin-treated patients. Both drugs were well tolerated. Two patients dropped out for treatment-related adverse events. CONCLUSIONS: The high urinary concentrations of prulifloxacin, combined with a broad-spectrum antimicrobial activity, allow its use in the empiric therapy of UTIs.

Effects of ibopamine eye drops on intraocular pressure and aqueous humor flow in healthy volunteers and patients with open-angle glaucoma.

PURPOSE: On the basis of intraocular pressure measurements and fluorophotometry we assessed the effects of 2% ibopamine eye drops on aqueous humor production in normal and glaucomatous eyes. METHODS: Thirty subjects (15 healthy volunteers and 15 open-angle glaucoma patients with ocular hypertension) were included in a placebo-controlled study with random assignment of treatment from masked containers. All subjects underwent ophthalmologic examinations and intraocular pressure (IOP) measurements. Fluorophotometry was done in both eyes at baseline (without treatment) and during treatment. Each subject was treated with 1 drop of 2% ibopamine in one eye and 1 drop of placebo in the fellow eye 30 minutes before fluorophotometric scans and every hour after the first instillation (for a total of 4 times). Safety was evaluated by recording adverse events and ocular symptoms and signs. Aqueous humor flow data were analyzed using the paired t-test, comparing ibopamine and placebo-treated eyes. RESULTS: No changes in IOP were detected in normal eyes, whereas glaucomatous eyes showed a mean increase of 4 mmHg (95% CI 3.46-4.51) from baseline. The difference in IOP between healthy eyes and those with glaucoma was significant (p < 0.0001). In normal eyes and patients with glaucoma ibopamine led to a significant increase in aqueous humor flow compared with placebo-treated eyes (p < 0.01). The safety profile of ibopamine was very good. CONCLUSIONS: The results seem to confirm that ibopamine increases aqueous humor production in normal and glaucomatous eyes, raising IOP only in eyes with glaucoma.

Cisplatin ototoxicity in the Sprague Dawley rat evaluated by distortion product otoacoustic emissions.

The present study has evaluated the use of distortion product otoacoustic emission (DPOAE) responses in the detection of cisplatin-induced ototoxicity in a Sprague Dawley rat animal model. The cisplatin was administered as a 16 mg/kg, dose introduced by a slow 30-min intraperitoneal infusion. Data from three DP-gram protocols, DPOAE input-output responses at 8 kHz, and auditory brainstem responses (ABRs) at 8, 12 and 16 kHz were collected before and 72 h after treatment. The post-treatment ABRs at 16 kHz showed the greatest mean threshold shift of 33.6 dB. The post-treatment DP-gram data showed significant reduction of the signal to noise ratios in the majority of the frequencies tested, across all tested protocols. The data suggest that the most sensitive DPOAE procedure for the early detection of the cisplatin-induced ototoxic damage is the DPOAE I/O protocol. Morphological analyses indicated that the inner hair cells remained intact, while several types of alterations were observed in the arrangement of the stereocilia in the outer hair cells.

Hearing in the elderly: a population study.

An epidemiological study comparing speech audiometry with self-assessed hearing disability and an analysis of other factors influencing the quality of life was conducted. In the Veneto region (Italy), a representative sample of 2700 independently living individuals of 65 years of age and older was selected for the study. All participants were administered a comprehensive questionnaire and a brief examination at their home, including a general physical examination, speech audiometry, Sanders' Speech Disability test, part I and III, Mini Mental State Examination, CES-D scale for depression, visual acuity, self-reported diseases and physical function. Auditory function was worst in the older individuals: auditory performance was within acceptable limits up to the 75-79 age group, while it rapidly deteriorates in the older groups. This trend is consistent with self-reported auditory disability (Sanders' test). A detailed analysis of the type of errors made in the speech audiometry was conducted for each subject. Speech audiometry is a good indicator of real hearing difficulties faced by the elderly, and it might be preferred to pure-tone audiometry, since hearing deficits with age are not always limited to an increased detection threshold, but include other aspects of hearing such as distortion of sounds, comprehension of speech and noise discrimination.

Clinical applicability of transient evoked otoacoustic emissions: identification and classification of hearing loss.

The study aimed at the development of a clinically applicable methodology that could: (1) discriminate transient evoked otoacoustic emission (TEOAE) recordings from normal hearing or hearing impaired individuals; (2) classify the nature of the hearing loss as conductive or as cochlear, and (3) define clear-cut TEOAE clinical criteria. A classification algorithm based on a multivariate discriminant analysis of fast Fourier transform data from recordings evoked by click stimuli of 50 +/- 2, 62 +/- 2, 68 +/- 2 and 80 +/- 2 dB SPL was used to discriminate 302 normal subjects from 383 subjects suffering from mild to moderate hearing losses. The best discriminant model (QDF80) produced a sensitivity of 93.8% and a specificity of 79.4%. When extra correlation criteria were serially applied to the classification outcome, the specificity was increased to 85.3%, but the sensitivity was marginally decreased to 91.7%. The classification of the correctly identified hearing-impaired cases yielded 93.8% identification of conductive and 75.1% identification of cochlear cases. A sensitivity analysis of the misclassified hearing-impaired cases suggested that the TEOAE spectra are well correlated with the 2-kHz but poorly correlated with the 4-kHz octave frequency.

Comparative bioavailability study of two oral formulations of ibuprofen.

The pharmacokinetic profile of ibuprofen (CAS 15687-27-1) in a Fast Melting Tablet (FMT), a modified release formulation (encapsulation of the active ingredient in gastroresistant microcapsules), was compared with that of sugar coated tablets (SCT; Moment 200). In the following paper an open, single dose, cross-over study in eighteen healthy volunteers (9 males and 9 females--mean age 27 years) is reported. The results of the study demonstrated that the rate of absorption of the FMT was markedly slower than that of the SCT. In fact, the geometric mean peak plasma concentration (Cmax) and median peak time (tmax) were 12.04 micrograms/ml at 3.5 h with the new formulation, and 18.71 micrograms/ml at 1 h with the SCT, respectively. The longer absorption time and diminished peak plasma concentration did not affect the extent of absorption of the two formulations, expressed by AUCo-t and AUC (90% confidence interval: 0.89-1.00 for AUCo-t and 0.92-1.03 for AUC). The safety profile of both drugs proved to be very good and no clinically significant adverse events were observed.

Bindarit prolongs survival and reduces renal damage in NZB/W lupus mice.

OBJECTIVE: The present study was designed to investigate the effects of bindarit on animal survival and renal damage in murine lupus autoimmune disease. METHODS: Female NZB/W mice were used. Bindarit was administered, as a 0.5% medicated diet, starting either before the onset of the pathology or early in the course of the disease, in order to assess the effects of age upon the response. Furthermore, the effects of combined administration of bindarit with low dose i.p. cyclophosphamide bolus were also studied. Proteinuria and anti-dsDNA antibody levels were determined during the course of the study. Renal damage was evaluated by light microscopy. RESULTS: Bindarit markedly prolonged the NZB/W mouse life span (p < 0.001 vs. controls), showing a significant difference even against high dose cyclophosphamide (90 mg/kg ip bolus) chosen as the reference (p < 0.01). Bindarit significantly reduced the degree of renal damage, delayed proteinuria and did not prevent autoantibody development, thus confirming the lack of immunosuppressive activity. CONCLUSION: The present results and other experimental data demonstrating the capacity of the drug to interfere with the inflammatory and immune response cross-talking, indicate that bindarit exerts its action in murine lupus through a novel and original mechanism. These findings, coupled with the evidence that the drug possesses a very safe toxicological profile, suggest that further investigations to assess the potential value of bindarit in the treatment of SLE are warranted.

[Loudness scaling for narrow band noise and speech signal]. / Stime categoriche di loudness per rumore a banda stretta e per segnale vocale.

A group of normal-hearing subjects underwent an experimental procedure to obtain estimates of loudness for two narrow band noises, centered at 0.25 and 3 kHz respectively, and meaningful unfiltered speech signals (sentences). Stimuli consisted of 12 intensity levels, spaced equally over the dynamic auditory range. The subjects were asked to associate each level of intensity to one 7 loudness categories. The loudness growth for a noise bands is defined by an exponential function. The loudness growth for the speech signal is better approximated by a linear function. However the mean intensity/loudness function shows two steep portions at the low and high intensities and these are separated by a shallow tract between 55 and 75 dB SPL. The loudness growth for meaningful speech signals--differing from the typical exponential function shown by noise stimuli--seems to confirm the contribution of factors that depend on central auditory organization, most likely operated by the perceptive auditory continuity attributes and the semantic content of the speech signals.

Benzydamine protection in a mouse model of endotoxemia.

OBJECTIVE: Previous studies have shown that benzydamine (40 mg/kg s.c.) is able to inhibit tumor necrosis factor (TNF) production and to reduce mouse lethality when administered before or concomitantly with LPS. The present study was designed to further investigate benzydamine activity against LPS-induced toxicity in terms of potency and therapeutic effects. METHODS: Female Balb/c mice were used. A dose-response curve of animal lethality versus endotoxin dose was performed (LD50 = 45 micrograms/mouse). Therapeutic effects were studied selecting the dose of LPS to achieve an LD100 (160 micrograms/mouse). Mortality was assessed daily and mice were followed for 8 days. The potential mode of action of therapeutically administered benzydamine was also investigated. TNF alpha and IL-1 beta levels were measured, at 5 h after LPS injection, both in sera and in lungs. Moreover, the drug was assayed in a TNF-dependent cytoxicity test. RESULTS: Benzydamine, administered at 20 mg/kg s.c. simultaneously with the endotoxin, significantly increased LPS LD50 up to 230 micrograms/mouse (p < 0.05). Moreover, the drug significantly protected mice against LPS-induced lethality when administered either 30 min or 4 h after endotoxin injection (p < 0.001). Benzydamine, therapeutically administered at 20 mg/kg s.c., significantly reduced TNF alpha and IL-1 beta production induced by LPS both in serum and lungs and it was shown to inhibit TNF-dependent cytoxicity on L929 cells. CONCLUSIONS: These results clearly demonstrate the therapeutic activity of benzydamine in a simple model of endotoxic shock. Available data confirm the potential role of benzydamine as an anti-cytokine agent and provide suggestions for novel therapeutic applications of this anti-inflammatory drug.

Audiometric patterns of genetic non-syndromal sensorineural hearing loss.

Sixty-five families with non-syndromal sensorineural hearing loss (NS-SNHL) of genetic aetiology were subtyped according to Gorlin et al. Individual audiogram shapes were also classified in order to detect inter- and intra-familial variations. In 48 families with an Autosomal Dominant (AD) inherited form, 26 exhibited the features of (high-frequency) progressive NS-SNHL, 12 those of mid-frequency NS-SNHL, 5 were affected by congenital low-frequency NS-SNHL; 1 kindred showed a progressive low-frequency pattern and another 1 a unilateral NS-SNHL; only 3 kindreds were affected by severe congenital NS-SNHL. Autosomal Recessive (AR) inherited forms were composed of 9 kindreds with severe congenital NS-SNHL, and 7 with moderate congenital NS-SNHL. One X-linked form was identified. AD- and AR-inherited NS-SNHL differed significantly both in severity of hearing impairment and in audiogram shapes. With few exceptions, in each family classified according to Gorlin, most of the affected subjects shared the same audiogram profile. Intrinsic progression of the disease versus ageing was studied in the larger subtype of individuals with the high-frequency loss. Gorlin's classification still remains the best system to classify NS-SNHL, and can provide a broad base to separate a very heterogeneous group of disorders. Results obtained in gene mapping in single large human families or in homologous gene search could be tested in our families. For some of them, namely those with high frequency progressive and low-frequency NS-SNHL, testing should already be feasible.

[Influence of a CNS pathology on the electrocochleography response]. / Alterazioni dei potenziali elettrococleografici in presenza di patologie del sistema nervoso centrale.

This study analyzed 73 electrocochleographic recordings made in children with a normal hearing threshold, selected retrospectively from 1563 recordings made between 1973 and 1990. The aim of the study was to check the original findings for any correlation between the various response parameters which might be indicative of a pathological condition. Compound action potential (AP) latency and amplitude, presynaptic summation potential (SP) and cochlear microphonic (CM) amplitudes and AP rapid adaptation behavior were calculated and recordings were associated with clinical information on aetiologic diagnosis, otoscopic examination, impedance measurement data and the finding of any central nervous system (CNS) pathology. The trend of the amplitudes as a function of the intensity of all three potentials (input-output functions), CM and SP in particular, demonstrated unexpected scattered values especially towards the high intensities. This was found correlated to the presence of CNS pathology. The comparison between the two groups (with vs without CNS pathology) with the aid of the Student's t-test proved statically significant, especially for CM and SP amplitudes while rather less so for AP amplitude. In particular, all CM and SP amplitude values outside the confidence intervals (calculated as 95% of normal cases) revealed CNS pathology. It has been suggested that the influence of the CNS on cochlear function is due to a disturbed function of the olicocochlear bundle, which is known to have an inhibitory effect on cochlear dynamics; furthermore, there is also proof that it can be activated regardless of any ipso-and/or contra-lateral acoustic stimulation. The effects observed on the electrocochleography in cases with CNS disorders would thus be explained by an interruption of the olivocochlear bundle at the CNS level or a disruption of the CNS mechanism capable of controlling its activation.