Intracochlear pressure as an objective measure for perceived loudness with bone conduction implants.

BACKGROUND: The generally accepted method to assess the functionality of novel bone conduction implants in a preclinical stage is to experimentally measure the vibratory response of the cochlear promontory. Yet, bone conduction of sound is a complex propagation phenomenon, depending on both frequency and amplitude, involving different conduction pathways. OBJECTIVES: The aim of this study is to validate the use of intracochlear sound pressure (ICP) as an objective indicator for perceived loudness for bone conduction stimulation. It is investigated whether a correlation exists between intracochlear sound pressure measurements in cadaveric temporal bones and clinically obtained results using the outcome of a loudness balancing experiment. METHODS: Ten normal hearing subjects were asked to balance the perceived loudness between air conducted (AC) sound and bone conducted (BC) sound by changing the AC stimulus. Mean balanced thresholds were calculated and used as stimulation levels in a cadaver trial (N = 4) where intracochlear sound pressure was measured during AC and BC stimulation to assess the correlation with the measured clinical data. The intracochlear pressure was measured at the relatively low stimulation amplitude of 80 dBHL using a lock-in amplification technique. RESULTS: Applying AC and BC stimulation at equal perceived loudness on cadaveric heads yield a similar differential intracochlear pressure, with differences between AC and BC falling within the range of variability of normal hearing test subjects. CONCLUSION: Comparing the perceived loudness at 80 dB HL for both AC and BC validates intracochlear pressure as an objective indicator of the cochlear drive. The measurement setup is more time-intensive than measuring the vibratory response of the cochlear promontory, yet it provides direct information on the level of the cochlear scalae.

Towards a unification of treatments and interventions for tinnitus patients: The EU research and innovation action UNITI.

Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much progress has been made, tinnitus remains a scientific and clinical enigma of high prevalence and high economic burden, with an estimated prevalence of 10%-20% among the adult population. The EU is funding a new collaborative project entitled "Unification of Treatments and Interventions for Tinnitus Patients" (UNITI, grant no. 848261) under its Horizon 2020 framework. The main goal of the UNITI project is to set the ground for a predictive computational model based on existing and longitudinal data attempting to address the question of which treatment or combination of treatments is optimal for a specific patient group based on certain parameters. Clinical, epidemiological, genetic and audiological data, including signals reflecting ear-brain communication, as well as patients' medical history, will be analyzed making use of existing databases. Predictive factors for different patient groups will be extracted and their prognostic relevance validated through a Randomized Clinical Trial (RCT) in which different patient groups will undergo a combination of tinnitus therapies targeting both auditory and central nervous systems. From a scientific point of view, the UNITI project can be summarized into the following research goals: (1) Analysis of existing data: Results of existing clinical studies will be analyzed to identify subgroups of patients with specific treatment responses and to identify systematic differences between the patient groups at the participating clinical centers. (2) Genetic and blood biomarker analysis: High throughput Whole Exome Sequencing (WES) will be performed in well-characterized chronic tinnitus cases, together with Proximity Extension Assays (PEA) for the identification of blood biomarkers for tinnitus. (3) RCT: A total of 500 patients will be recruited at five clinical centers across Europe comparing single treatments against combinational treatments. The four main treatments are Cognitive Behavioral Therapy (CBT), hearing aids, sound stimulation, and structured counseling. The consortium will also make use of e/m-health applications for the treatment and assessment of tinnitus. (4) Decision Support System: An innovative Decision Support System will be implemented, integrating all available parameters (epidemiological, clinical, audiometry, genetics, socioeconomic and medical history) to suggest specific examinations and the optimal intervention strategy based on the collected data. (5) Financial estimation analysis: A cost-effectiveness analysis for the respective interventions will be calculated to investigate the economic effects of the interventions based on quality-adjusted life years. In this paper, we will present the UNITI project, the scientific questions that it aims to address, the research consortium, and the organizational structure.

Alteration of the relative vibration of the round window membrane after implantation of a direct acoustic cochlear implant.

Objective: Subjects implanted with a Direct Acoustic Cochlear Implant (DACI) show improvements in their bone conduction (BC) thresholds after surgery. We hypothesised that a new pathway for BC sound is created via the DACI. The aim of this study was to investigate the contribution of this pathway to the cochlear response via measurements of the promontory and round window membrane (RWM) velocities while stimulating with a conventional bone conductor.Design: This study was a cadaver head study with a repeated measures study design.Study Sample: Eight ears of five fresh-frozen cadaveric whole heads were investigated in this trial.Results: After DACI implantation the promontory and RWM velocities did not change significantly in the frequency range 0.5-2 kHz when the DACI was switched off.Conclusions: No significant changes in the relative vibration magnitude of the RWM after DACI implantation were observed. The improvements in BC thresholds seen in patients implanted with a DACI very likely have their origin in the changed impedance at the oval window after DACI surgery leading to a more efficient contribution from the inner ear components to BC sound.

Development and validation of a method to record electrophysiological responses in direct acoustic cochlear implant subjects.

Acoustic hearing implants, such as direct acoustic cochlear implants (DACIs), can be used to treat profound mixed hearing loss. Electrophysiological responses in DACI subjects are of interest to confirm auditory processing intra-operatively, and to assist DACI fitting postoperatively. We present two related studies, focusing on DACI artifacts and electrophysiological measurements in DACI subjects, respectively. In the first study we aimed to characterize DACI artifacts, to study the feasibility of measuring frequency-specific electrophysiological responses in DACI subjects. Measurements of DACI artifacts were collected in a cadaveric head to disentangle possible DACI artifact sources and compared to a constructed DACI artifact template. It is shown that for moderate stimulation levels, DACI artifacts are mainly dominated by the artifact from the radio frequency (RF) communication signal, that can be modeled if the RF encoding protocol is known. In a second study, the feasibility of measuring intra-operative responses, without applying the RF artifact models, in DACI subjects is investigated. Auditory steady-state and brainstem responses were measured intra-operatively in three DACI subjects, immediately after implantation, to confirm proper DACI functioning and coupling to the inner ear. Intra-operative responses could be measured in two of the three tested subjects. Absence of intra-operative responses in the third subject can possibly be explained by the hearing loss, attenuation of intra-operative responses, the difference between electrophysiological and behavioral threshold, and a temporary threshold shift due to the DACI surgery. In conclusion, RF artifacts can be modeled, such that electrophysiological responses to frequency-specific stimuli could possibly be measured in DACI subjects, and intra-operative responses in DACI subjects can be obtained.

Transient and steady state auditory responses with direct acoustic cochlear stimulation.

OBJECTIVES: Direct acoustic cochlear implants directly stimulate the cochlear fluid of the inner ear by means of a stapes piston driven by an actuator and show encouraging speech understanding in noise results for patients with severe to profound mixed hearing loss. Auditory evoked potentials recorded in such patients would allow for the objective evaluation of the aided auditory pathway. The aim of this study was (1) to develop a stimulation setup for EEG recordings in subjects with direct acoustic cochlear implants, (2) to show the feasibility of recording auditory brainstem responses (ABRs) and auditory steady state responses (ASSRs), and (3) to analyze the relation between electrophysiological thresholds derived from these responses and behavioral thresholds. DESIGN: For the three subjects implanted during a phase Ib clinical study in the authors' center, ABRs and 40 and 80 Hz ASSRs were recorded with a straightforward acoustic stimulation setup and a newly developed direct stimulation setup. Click trains with rates around 40 Hz and around 90 Hz were used as stimuli. By comparing amplitude growth function and phase delay in the same stimulus range, validity of the responses was confirmed. RESULTS: With the acoustic stimulation setup, stimulation artifacts made it impossible to analyze responses. With the direct stimulation setup, stimulation artifacts could be removed completely and responses could be successfully recorded in a noninvasive manner in all subjects. Response properties such as ABR peak V latencies and ASSR apparent latencies were similar to those for acoustic stimulation, with apparent latencies of 39.9 and 24.7 msec for 40 and 90 Hz, respectively. Electrophysiological thresholds could be objectively determined from the ABRs and ASSRs. In the 40 Hz range, the mean difference between electrophysiological ASSR thresholds and behavioral ones was 12 dB. CONCLUSION: The results show that auditory evoked potential measurements with the developed direct stimulation setup are feasible and meaningful and should be further investigated to provide intraoperative feedback about the coupling of the actuator to the inner ear.