Intraoperative quantification of floating mass transducer coupling quality in active middle ear implants: a multicenter study.

PURPOSE: Evaluating the effectiveness of intraoperative auditory brainstem responses (ABRs) to stimulation by the Vibrant Soundbridge (VSB) active middle ear implant for quantifying the implant's floating mass transducer (FMT) coupling quality. METHODS: In a diagnostic multicentric study, patients (> 18 years) who received a VSB with different coupling modalities were included. Pre- and postoperative bone conduction thresholds, intraoperative VSB-evoked ABR thresholds (VSB-ABR) using a modified audio processor programmed to preoperative bone conduction thresholds, postoperative vibrogram thresholds, and postoperative VSB-ABR thresholds were measured. Coupling quality was calculated from the difference between the pure tone average at 1000, 2000, and 4000 Hz (3PTA) vibrogram and postoperative 3PTA bone conduction thresholds. RESULTS: Twenty-three patients (13 males, 10 females, mean age 56.6 (± 12.5) years) were included in the study. Intraoperative VSB-ABR response thresholds could be obtained in all except one patient where the threshold was > 30 dB nHL. Postoperatively, an insufficient coupling of 36.7 dB was confirmed in this patient. In a Bland-Altman analysis of the intraoperative VSB-ABRs and coupling quality, the limits of agreement exceeded ± 10 dB, i.e., the maximum allowed difference considered as not clinically important but the variation was within the general precision of auditory brainstem responses to predict behavioral thresholds. Five outliers were identified. In two patients, the postoperative VSB-ABR thresholds were in agreement with the coupling quality, indicating a change of coupling before the postoperative testing. CONCLUSION: The response thresholds recorded in this set-up have the potential to predict the VSB coupling quality and optimize postoperative audiological results.

The accuracy of objective threshold determination at low frequencies: comparison of different auditory brainstem response (ABR) and auditory steady state response (ASSR) methods.

OBJECTIVE: The hearing threshold at 500 Hz was estimated using five methods which are suitable for the low frequency range: Low-Chirp BERA (LCBERA), Notched-noise BERA (NNBERA), Narrow band CE-Chirp BERA (NBCBERA) and Narrow band CE-Chirp ASSR (NBCASSR) (40/90 Hz). The slope of the discrimination function of each method was used for determination of the most efficient method. The threshold values were compared and the corresponding odds ratios (OR) were calculated. DESIGN: All methods were applied to each subject. Stimulus levels were arranged individually. Response detection was carried out by visual inspection of the records in case of BERA and automatically in case of ASSR. Each individual series of recordings was converted to a dichotomous function indicating whether or not a response was discernible and a continuous method-specific discrimination function was constructed. This function was realised by a Boltzmann function whose slope in the inflection point serves as quality measure. Additionally, an OR evaluation was carried out in order to validate the significance of results. STUDY SAMPLE: Twenty five normal hearing adults (aged 18-30 years) were tested. RESULTS: LCBERA proved to have the highest reliability according to the slope of the Boltzmann function, the comparison of threshold values and OR. CONCLUSIONS: The LCBERA is recommended for use in routine clinical practice.

[Current Audiological Diagnostics]. / Aktuelle audiologische Diagnostik.

Today's audiological functional diagnostics is based on a stock of hearing tests, whose large number takes account of the variety of malfunctions of a complex sensory organ system and the necessity to examine it in a differentiated manner and at any age of life. The objective is to identify nature and origin of the hearing loss and to quantify its extent as far as necessary to dispose of the information needed to initiate the adequate medical (conservative or operational) treatment or the provision with technical hearing aids or prostheses. Moreover, audiometry provides the basis for the assessment of impairment and handicap and for the calculation of the degree of disability. In the present overview, the current state of the method inventory available for practical use is described, starting from basic diagnostics over to complex special techniques. The presentation is systematically grouped in subjective procedures, based on psychoacoustic exploration, and objective methods, based on physical measurements: preliminary hearing tests, pure tone threshold, suprathreshold processing of sound intensity, directional hearing, speech understanding in quiet and in noise, dichotic hearing, tympanogram, acoustic reflex, otoacoustic emissions and auditory evoked potentials. Apart from a few still existing gaps, this method inventory covers the whole spectrum of all clinically relevant functional deficits of the auditory system.

Optimized SNR-based ECAP threshold determination is comparable to the judgement of human evaluators.

In cochlear implant (CI) users, measurements of electrically evoked compound action potentials (ECAPs) prove the functionality of the neuron-electrode interface. Objective measures, e.g., the ECAP threshold, may serve as a basis for the clinical adjustment of the device for the optimal benefit of the CI user. As for many neural responses, the threshold determination often is based on the subjective assessment of the clinical specialist, whose decision-making process could be aided by autonomous computational algorithms. To that end, we extended the signal-to-noise ratio (SNR) approach for ECAP threshold determination to be applicable for FineGrain (FG) ECAP responses. The new approach takes advantage of two features: the FG stimulation paradigm with its enhanced resolution of recordings, and SNR-based ECAP threshold determination, which allows defining thresholds independently of morphology and with comparably low computational power. Pearson's correlation coefficient r between the ECAP threshold determined by five experienced evaluators and the threshold determined with the FG-SNR algorithm was in the range of r = 0.78-0.93. Between evaluators, r was in a comparable range of 0.84-0.93. A subset of the parameters of the algorithm was varied to identify the parameters with the highest potential to improve the FG-SNR formalism in the future. The two steps with the strongest influence on the agreement between the threshold estimate of the evaluators and the algorithm were the removal of undesired frequency components (denoising of the response traces) and the exact determination of the two time windows (signal and noise and noise only)."The parameters were linked to the properties of an ECAP response, indicating how to adjust the algorithm for the automatic detection of other neurophysiological responses.

Age dependence of otoacoustic emissions: the loss of amplitude is primarily caused by age-related hearing loss and not by aging alone.

The amplitude of otoacoustic emissions (OAE) is known to decrease with increasing age, but it is still unclear whether this is due to aging alone or to age-related hearing loss. This study describes the exploration of a large database (5,142 patients from 0.4 to 89.8 years) collected in a routine clinical testing. Reliable pure tone audiograms, transitory evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) recordings were available from 5,424 ears without conductive loss, acute sudden deafness or retrocochlear disorder. From this database, group 1 with behavioral thresholds of 10 dB HL or better at all frequencies from 1 to 4 kHz and group 2 with age-accordant thresholds after ISO 7029 were formed. In both groups, the OAE amplitude decreased with increasing age, but in group 1, the effect was significant only for DPOAE recorded at 3 and 4 kHz. In group 2, the loss of amplitude was steeper and highly significant for TEOAE as well as DPOAE at all frequencies, but most pronounced at high frequencies. These findings support the hypothesis that the reduction of OAE amplitude with increasing age is primarily caused by age-linked hearing loss and not by aging alone.

Intraoperative Recording of Auditory Brainstem Responses for Monitoring of Floating Mass Transducer Coupling Efficacy During Revision Surgery-Proof of Concept.

OBJECTIVE: The objective of the study was to measure auditory brainstem responses elicited by stimulation via a semi-implantable active middle ear implant with an electromagnetically driven floating mass transducer to quantify the coupling efficacy (=vibroplasty in situ thresholds - bone conduction thresholds) in a patient during a revision surgery. PATIENTS: One patient, reimplanted with an active middle ear implant in a revision surgery. INTERVENTION(S): Diagnostic. MAIN OUTCOME MEASURE(S): Intraoperative auditory brainstem responses evoked by stimulation via an active middle ear implant in a calibrated set-up directly indicating the coupling efficacy magnitude (auditory brainstem response threshold = coupling efficacy), as well as pre- and postoperative bone conduction and vibroplasty in situ thresholds. RESULTS: The intraoperative auditory brainstem response threshold was detected at 0 dB nHL, i.e., the magnitude of coupling efficacy was determined intraoperatively to be 0 dB. The actual postoperative coupling efficacy (=postoperative vibroplasty in situ - postoperative bone conduction thresholds) was -2.5 dB. CONCLUSIONS: The coupling efficacy determined intraoperatively was consistent with the postoperative coupling efficacy. The described method seems to be a promising tool to objectively quantify the magnitude of coupling efficacy in active middle ear implant surgeries.

A new approach for the determination of ECAP thresholds.

BACKGROUND: Electrically evoked compound action potentials (ECAPs) of the auditory nerve are routinely recorded for testing the cochlear implant integrity and its functional connection to the auditory system. The response thresholds derived from ECAP recordings are widely used as a helpful guide in the fitting of the dynamic range of electric stimulation, although they may not always predict the behavioral thresholds of individuals well. Conventionally, this threshold is based on the identification of a minimum N peak and maximum P peak and linear extrapolation of the resulting amplitude growth function (AGF). As an alternative, a new procedure involving numeric signal processing and requiring less user intervention is presented here. Data acquisition: In 12 adults implanted with MED-EL FLEX28 electrodes, two series of ECAPs were recorded immediately after implantation: (i) a full profile involving all 12 channels across the whole stimulus range in steps of 200 current units and (ii) a high resolution section (20 records in the immediate neighborhood of the threshold) of the AGF in one selected channel. Data treatment: It was observed that N and P wave latencies do not depend on stimulus intensity. Fixed time windows were hence defined for stimulus plus noise and noise alone regions. In these windows, the variance of the compound signal representing response and noise is extracted, whereas the noise variance is extracted from the tail of the curve following this time window. The base line is corrected by fitting an exponential function to reduce stimulus or amplifier artifacts. The response threshold is then derived from the response to noise ratio which should exceed the limit of 6 dB. RESULTS: The ECAP thresholds obtained from the new procedure coincide well with those determined by the conventional linear extrapolation of the AGF and they correlate to a greater degree with psychometric thresholds than the existing approach. CONCLUSIONS: The new ECAP algorithm looks promising and may reduce the need for user intervention in determining thresholds.

Current audiological diagnostics.

Today's audiological functional diagnostics is based on a variety of hearing tests, whose large number takes account of the variety of malfunctions of a complex sensory organ system and the necessity to examine it in a differentiated manner and at any age of life. The objective is to identify nature and origin of the hearing loss and to quantify its extent as far as necessary to dispose of the information needed to initiate the adequate medical (conservative or operational) treatment or the provision with technical hearing aids or prostheses. Moreover, audiometry provides the basis for the assessment of impairment and handicap as well as for the calculation of the degree of disability. In the present overview, the current state of the method inventory available for practical use is described, starting from basic diagnostics over to complex special techniques. The presentation is systematically grouped in subjective procedures, based on psychoacoustic exploration, and objective methods, based on physical measurements: preliminary hearing tests, pure tone threshold, suprathreshold processing of sound intensity, directional hearing, speech understanding in quiet and in noise, dichotic hearing, tympanogram, acoustic reflex, otoacoustic emissions and auditory evoked potentials. Apart from a few still existing gaps, this method inventory covers the whole spectrum of all clinically relevant functional deficits of the auditory system.

The Role of Auditory Evoked Potentials in the Context of Cochlear Implant Provision.

: Auditory evoked potentials (AEP) are highly demanded during the whole process of equipping patients with cochlear implants (CI). They play an essential role in preoperative diagnostics, intraoperative testing, and postoperative monitoring of auditory performance and success. The versatility of AEP's is essentially enhanced by their property to be evokable by acoustic as well as electric stimuli. Thus, the electric responses of the auditory system following acoustic stimulation and recorded by the conventional surface technique as well as by transtympanic derivation from the promontory (Electrocochleography [ECochG]) are used for the quantitative determination of hearing loss and, additionally, electrically evoked compound actions potentials (ECAP) can be recorded with the intracochlear electrodes of the implant just adjacent to the stimulation electrode to check the functional integrity of the device and its coupling to the auditory system. The profile of ECAP thresholds is used as basis for speech processor fitting, the spread of excitation (SOE) allows the identification of electrode mislocations such as array foldover, and recovery functions may serve to optimize stimulus pulse rate. These techniques as well as those relying on scalp surface activity originating in the brainstem or the auditory cortex accompany the CI recipient during its whole life span and they offer valuable insights into functioning and possible adverse effects of the CI for clinical and scientific purposes.

Field study to explore possible effects of styrene on auditory function in exposed workers.

OBJECTIVES: We conducted this study to examine, whether occupational styrene exposures are associated with reduced hearing ability. METHODS: The auditory function was investigated by pure tone audiometry and registration of transitory evoked otoacoustic emissions (TEOAE) in 32 workers of a fibre-reinforced plastic boat building factory. Sixteen subjects were laminators (mean age: 41 yr (SD: 8)) and therefore regularly exposed to styrene with mean duration of exposure to styrene of 7.5 yr (SD 5.0). The tests were applied to a reference group of 16 workers (mean age: 39 yr (SD: 8)) who were not directly exposed to styrene but had a similar noise exposure. RESULTS: A few and isolated correlations between the parameters of hearing acuity and exposure indices, such as current internal styrene exposures (sum of MA and PGA) and duration of styrene exposure, were statistically significant, but no consistent association was found. CONCLUSION: The results of this study do not support the assumption of an ototoxic effect of chronic styrene exposure in workers.

Cochlear implantation in recipients with single-sided deafness: Audiological performance.

OBJECTIVE: To examine the auditory benefit of cochlear implants (CI) in patients with single-sided deafness (SSD). MATERIAL AND METHODS: Twenty patients with a normal pure tone audiogram (n = 8) or moderate hearing loss (n = 12) in one ear and a CI system MED-EL SONATA/CONCERTO + OPUS2 (n = 12), COCHLEAR CI24RE(ST) + CP810 (n = 7) and Advanced Bionics HiRes90 K + Harmony (n = 1) in the contralateral ear and with at least 6 months of CI experience were tested with respect to directional hearing, speech perception in noise, binaural loudness matching, and binaural pitch matching. Twenty-six normal hearing controls were included for normative reference. RESULTS: Addition of the CI significantly improves directional hearing (percentage of correct source identifications improved from 14.9 to 15.6%, root mean square error decreased from 125 to 93°) and improves speech perception in noise (speech perception threshold median improved from -2.3 to -6.0 dB signal to noise ratio, equivalent to a binaural intelligibility level difference = 3.7 dB). Alternate binaural loudness balancing showed that matching takes place at levels between 48 and 55 dB HL (group averages). In the pitch matching experiment, the standard deviation of the relative interaural frequency difference at 500, 1000, and 2000 Hz was 24.5, 22.8, and 24.0%, respectively (compared to 11.7, 14.4, and 12.3% in the control group). CONCLUSIONS: In SSD, cochlear implantation considerably improves audiological performance in terms of directional hearing, binaural signal equivalence, and speech perception.

Investigation of ototoxicity of artesunate as add-on therapy in patients with metastatic or locally advanced breast cancer: new audiological results from a prospective, open, uncontrolled, monocentric phase I study.

PURPOSE: Artesunate (ART) has been used for a long time in the treatment of Plasmodium falciparum malaria and has been considered safe. The present phase I study aimed to determine the daily dose of ART that is well tolerated as add-on therapy in patients with breast cancer for 4 weeks of therapy. Ototoxicity could be a potential safety concern in settings different from malaria. Therefore, comprehensive audiological assessment was essential. METHODS: The ARTIC M33/2 study was a prospective, open, uncontrolled, monocentric phase I dose-escalation study to evaluate the safety and tolerability of ART in patients with advanced breast cancer. Patients received either 100, 150 or 200 mg oral ART daily for a test phase of 4 weeks as add-on therapy to their ongoing oncological treatment. For the investigation of the safety of ART for hearing, an audiological assessment was performed with each patient before the intake of ART and after 4 weeks of therapy. RESULTS: Twenty-three female patients were included in the study. During the test phase, four patients had adverse events (AEs) of the auditory system possibly related to the intake of ART. However, none of these AEs was classified as severe AE (SAE) and did not require treatment interruption. Four patients had AEs concerning the vestibular system (vertigo) during the test phase, one of which was classified as SAE. However, the SAE was fully reversible after discontinuation of ART. CONCLUSION: None of the audiological results after 4 weeks of therapy with ART showed any dose-limiting auditory toxicity. However, audiological monitoring in further clinical studies with prolonged use of oral ART in doses up to 200 mg daily is warranted. The ARTIC M33/2 study is registered at eudract.ema.europa.eu with the Number 2007-004432-23 and at clinicaltrials.gov with the Number NCT00764036.

First clinical experiences with a direct acoustic cochlear stimulator in comparison to preoperative fitted conventional hearing aids.

OBJECTIVE: Patients with moderate-to-severe mixed hearing losses (MHLs) are hard to provide sufficient benefit with currently available conventional hearing aids. Here, the long-term safety of a direct acoustic cochlear stimulator (DACS) and the effectiveness compared with conventional "high-performance" hearing aids were investigated. STUDY DESIGN: Prospective, within patient reference, nonrandomized, interventional multicenter clinical study performed at these 3 centers: Medical University Hannover, University of Heidelberg, and Helios Hospital Krefeld. PATIENTS AND INTERVENTION: Ten otosclerosis patients with severe-to-profound MHL were preoperatively fitted with state-of-the-art conventional hearing aids (HA). After 2 months of testing conventional HA, 9 of the patients decided to be implanted with a DACS. MAIN OUTCOME MEASURES: Air conduction (AC) and bone conduction (BC) aided and unaided thresholds, speech discrimination before and after implantation and at 3, 6, and 12 months after activation. The subjective benefit was assessed by the Abbreviated Profile of Hearing Aid Benefit (APHAB). RESULTS: Preoperative hearing thresholds were preserved over the 12 month observation time after activation. Average functional gain (0.5-4 kHz) achieved with conventional HA was 47 dB compared with 56 dB with the DACS. Speech-in-noise tests revealed a lower SNR for DACS (3.1 dB) than for the HA (6.6 dB) and patients were more satisfied with the DACS. CONCLUSION: The DACS significantly improved hearing, speech intelligibility, and satisfaction in patients with a severe-to-profound mixed hearing loss and can be considered a safe and useful alternative to conventional hearing aids.

Indication for the need of flexible and frequency specific mapping functions in cochlear implant speech processors.

Categorical loudness scaling of electric and acoustic stimuli was performed in cochlear implant (CI) recipients equipped with Nucleus systems in order to achieve a normal loudness perception in the whole dynamic range of acoustic input. For each electrode, the lower and upper limits of electric stimulus were defined by the values corresponding to "very soft" and "too loud". Within this dynamic range, the stimulus strength intervals associated to the verbal categories "soft", "medium", "loud" and "very loud" were determined. The same loudness categories were used for the scaling of acoustic stimuli. From both scaling experiments, the transduction of the CI system can be assessed and the parameters of the individual mapping function yielding a normal loudness growth can be derived. Deviations from optimum mapping can be corrected at least partially by manipulating the parameters of the mapping function. In many cases, however, one mapping function is not sufficient for all channels. The results argue in favour of the development of flexible and channel-specific mapping function parameters in future CI systems.

TEOAE amplitude growth, detectability, and response threshold in linear and nonlinear mode and in different time windows.

Transitory evoked otoacoustic emissions (TEOAE) have been recorded in 60 ears of 31 adult volunteers with nearly normal hearing at stimulus levels ranging from 83 dB SPL peak equivalent down to the individual response threshold using linear and nonlinear recording mode. The stimulus level dependence of response incidence and amplitude has been analysed for the integral response and in time windows selecting response components of limited latency ranges. At stimulus levels above 70 dB SPL peak equivalent the TEOAE records received in linear mode are contaminated with stimulus artifacts. At moderate stimulus levels the TEOAE amplitude differs only to a small extent between the two recording modes. At low levels the linear mode turns out to be better suited for signal detection due to its inherent lower noise level. The response threshold, defined as the highest stimulus level yielding a reproducibility of at least 60%, is significantly correlated to hearing threshold. The consideration of time windowed responses yields best results with respect to incidence and threshold of responses in the latency range between 5 and 10 ms, but it does not enhance frequency specificity.

Auditory status of persons with intellectual disability at the German Special Olympic Games.

Among persons with intellectual disability, the prevalence of hearing impairments is high. During the German Special Olympics Summer Games 2004, a hearing screening was conducted on 755 athletes with intellectual disabilities. Obligatory screening included ear inspection and recording of otoacoustic emissions, and optional screening included tympanometry and brief pure-tone audiometry. 38.0% of the athletes failed the screening. 53.0% needed ear wax removal. 56.1% of the fails indicated sensorineural hearing loss and 13.6% indicated mixed hearing loss. 12.5% of the fails were caused by unremovable ear wax, 1.4% by ear canal affections, and 16.4% by middle ear problems. Left ear fails were more frequent than right ear fails. A peripheral hearing disturbance can thus be expected in every third subject. The high failure rate, a considerable percentage of previously undetected profound hearing loss (1.1%), and the frequent need for ear wax removal, suggest that nearly half of persons with intellectual disabilities need regular otological or audiological consultations.

On a possible prognostic value of otoacoustic emissions: a study on patients with sudden hearing loss.

Otoacoustic emissions (OAE) and pure tone audiogram (PTA) were examined in 26 ears of 25 patients suffering from sudden hearing loss from the 1st day to up to 505 days following the drop of hearing to test the hypothesis whether the OAEs are capable of delivering predictive information about the recovery process. The patients were selected from 50 candidates according to the following criteria: one or both ears exhibited a systematic and significant recovery of pure tone threshold in at least one frequency, OAEs were detectable and PTA available, a conductive hearing loss was excluded, and the auditory brainstem responses (ABR) yielded no signs of retrocochlear disorders. Transitory evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) were measured under constant stimulus and recording conditions in three to nine sessions. The relation between OAE level and actual pure tone threshold was subject to a regression analysis. The correlation between both parameters is small but significant. Even smaller correlations are observed if the OAE level is related to former hearing loss, whereas the correlation improves if the OAE level is compared to the pure tone threshold measured in a later session. The slopes of individual trajectories that connect the successive results of one ear in a plane defined by hearing loss and OAE level show a remarkable accumulation around zero, i.e., in many cases the OAEs remain unchanged even if the hearing loss decreases. The comparison of the OAE levels measured at an early stage with later audiograms shows that there are only a small number of cases with small initial emissions and good final threshold or large initial emissions and bad final threshold. This means that small initial OAEs end up with a remaining final hearing deficit, whereas a high OAE level immediately after drop of threshold correlates with good outcome. The reliability of an individual prediction based on the OAE level combined with the threshold after sudden hearing loss and the consequences for the physiologic mechanisms underlying the sudden hearing loss remain to be proved in further investigations.

The interplay between glottis and vocal tract during the male passaggio.

The transition between 'chest' and 'head' register is essential for male opera singers in order to reach the higher pitches. The 'passaggio', which is a scale passage where this transition takes place, but also a maneuver of register equalization, is typically difficult to learn. Studies on parameters for a definition of this transition are restricted to a small number of singers so far. Audio, electroglottographic, and equivalent subglottic pressure signals of 11 male opera singers were recorded while singing scales on open back vowels and passing the register transition. A spectrum analysis of the audio signal revealed that the second harmonic (H2) dominates in 'chest', resonated by the first formant (F1), together with the fourth harmonic (H4), supported by the second formant (F2). During the passaggio, H2 level decreases because it loses the resonance of F1, while the third harmonic (H3) gains the resonance of F2. At this point the H4 level drops because that harmonic is no longer supported by F2. The transition from 'chest' to 'head' register is marked by characteristic changes in the amplitude patterns of the partials H2, H3, and H4, and the frequency progressions of the first two formants, defining an objective distinction between the two registers.