Primary: to evaluate the effect of three different available gain prescriptions for percutaneous bone anchored hearing aids on experienced speech understanding, loudness, sound quality, own-voice quality, and listening effort in real-life situations…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
EMA-ratings for the different programs.
Secondary outcome
Paired-comparison scores and speech perception scores for the different
programs.
Background summary
For patients with a mixed hearing loss, a Bone Conduction Device (BCD) is a
potential solution to rehabilitate hearing function. In case of a mixed hearing
loss a BCD applies gain to incoming sound to compensate for the sensorineural
part of the hearing loss. Manufacturers of BCDs use proprietary gain
prescription rules. There is limited published evidence on how much
amplification is needed for a given sensorineural hearing loss. In contrast,
for air conduction amplification there are several evidence-based prescription
rules to compensate for hearing loss. Two widely used prescription rules are
the Desired Sensation Level (DSL) and the NAL-NL2. Recently, a few studies
attempted to transform these prescription rules to be applicable for gain
prescription in BCD-fitting, resulting in a DSL-BCD and a NAL-NL2-BC gain
prescription (Hodgetts & Scollie, 2017; Toll & Dingemanse, 2022). A limitation
in the prescription of gain in a BCD is the limited maximum stable gain,
obtained with a feedback analysis, and the limited maximum force output,
especially in the low frequencies. The different prescription rules for BCD
address these limitations differently. This results in differences in applied
gain, especially in the lower frequencies, for soft speech, and loud speech.
The published evidence for the DSL-BCD and NAL-NL2-BC is still limited. For
clinicians, it would be beneficial if more evidence would be available about
which gain prescription leads to the best real-world experience for the
patient.
Study objective
Primary:
to evaluate the effect of three different available gain prescriptions for
percutaneous bone anchored hearing aids on experienced speech understanding,
loudness, sound quality, own-voice quality, and listening effort in real-life
situations with ecological momentary assessment in daily life and a virtual
reality environment.
Secondary:
• to evaluate the effect of three different available gain prescriptions for
percutaneous bone anchored hearing aids on speech recognition in quiet and
noise.
• to evaluate the overall preference for one of the different gain
prescriptions.
Study design
The study is a double-blind cross-over experimental study, that compares the
effect of three different available gain prescriptions for percutaneous
bone-anchored hearing aids within the same group of participants.
Study burden and risks
For a period of six weeks, participants must wear/use a specified type of bone
conduction hearing aid (Cochlear BAHA 6 Max); participants must listen to and
assess three different gain settings. These settings vary according to a
predefined schedule; the participant is not allowed to adjust settings that may
be perceived as suboptimal but he must 'endure' them for the period defined in
the schedule.
Additional effort and time investment: from day 19, the participant must wear a
microphone and interrupt his activities several times a day, for a few minutes,
to answer questions about listening experiences (this costs the participant
about 10 minutes a day).
The participants need to visit the Erasmus MC twice, with six weeks in between
(these visits are not part of standard care and require a time investment from
the participant of about 4 hours in total).
We expect no problems with acceptance of sound or deterioration of daily
auditory functioning during the study.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Mixed hearing loss, minimum bone conduction (BC) thresholds of 15 dBHL at 2
or more frequencies and maximum BC thresholds of 35 dBHL (average 1,2,4 kHz) to
avoid differences between fitting rules becoming smaller or even non-existent
because the required gain or output cannot be achieved due to device
limitations, for one or more fitting rules.
- At least 3 months of BCD-use
- Average air conduction thresholds at the contralateral side are at least 10
dB worse than the averaged unmasked BC thresholds, to prevent that the
contralateral ear determines the outcomes.
- Capable to answer questions on a smartphone.
- Fluent in Dutch.
- Minimum aided free-field word score with BCD of 85% at 65 dB SPL (for speech
recognition tests).
Exclusion criteria
- Single-sided deafness application of the BAHA.
- Reporting hyperacusis or severe sound sensitivity.
- Balance problems that result in suffering from motion sickness when wearing a
VR headset
- Astigmatism (curvature of the cornea), because this makes it impossible to
see in 3D when looking through a VR headset.
- The gain needed for each of the three gain prescriptions at 65 dBSPL input
cannot be applied within ± 3dB at two or more octave frequencies up to 4 kHz.
- At least one of the three gain prescriptions is unacceptable for the
participant or does not result in sufficient speech perception during a first
check in the VR environment.
- The compliance with the scheme of program selection was too low.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87416.078.24 |